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Hormone · Profile

Letrozole

Femara · Non-steroidal AI

Hormone ManagementApproved
MW
285.3g/mol
Formula
C17H11N5

Letrozole is a third-generation aromatase inhibitor primarily produced in the ovaries and adrenal glands, classified as a non-steroidal compound. Researchers primarily study letrozole for its role in ovulation induction in women with conditions such as polycystic ovary syndrome (PCOS) and as a first-line treatment for hormone receptor-positive metastatic breast cancer in postmenopausal women. Key findings indicate that letrozole can effectively induce ovulation in a significant percentage of women with anovulation and demonstrates considerable efficacy in prolonging progression-free survival in breast cancer patients. Additionally, studies suggest that alternative dosing protocols, such as the stair-step approach, may enhance treatment efficiency without compromising outcomes. Current research continues to explore letrozole's applications and effectiveness across various patient populations, highlighting its clinical relevance in reproductive health and oncology.

Overview

Übersicht

Letrozole is a synthetic non-steroidal aromatase inhibitor primarily used in hormone management. It is chemically classified as a triazole derivative and is not endogenously produced. Letrozole is synthesized for therapeutic use, particularly in the management of hormone-sensitive conditions. Researchers have found that letrozole plays a significant role in the treatment of hormone receptor-positive breast cancer, particularly in postmenopausal women, and is also used in fertility treatments for conditions like polycystic ovary syndrome (PCOS). It has been studied for its efficacy in ovulation induction and as a treatment for endometrial hyperplasia without atypia. The primary mechanism of action of letrozole involves the inhibition of the aromatase enzyme, which is responsible for the conversion of androgens to estrogens. By reducing estrogen levels, letrozole decreases the growth stimulus for estrogen-dependent tumors. This mechanism is crucial in the treatment of hormone receptor-positive breast cancer. Pharmacokinetically, letrozole is well absorbed orally, with a bioavailability of approximately 99.9%. It has a half-life of about 2 days, allowing for once-daily dosing. Letrozole is metabolized in the liver and excreted primarily via the kidneys. Clinically, letrozole is approved for use in postmenopausal women with hormone receptor-positive breast cancer and is also used off-label for fertility treatments. It is generally well-tolerated, with a favorable safety profile. Regulatory agencies like the FDA and EMA have approved its use in specific indications, reflecting its established role in hormone management therapies.

Chemical profile

Chemische Struktur

Chemical structure of Letrozole
FormelC17H11N5
Molekulargewicht285.3g/mol
CAS-Nummer112809-51-5
PubChem CID3902
Mechanism

Wirkmechanismus

Letrozole acts by inhibiting the aromatase enzyme, thereby reducing the conversion of androgens to estrogens. This reduction in estrogen levels decreases the growth stimulus for estrogen-dependent tumors, making it effective in hormone receptor-positive breast cancer treatment.

Mechanism

Signalweg

Letrozole is a selective aromatase inhibitor that decreases estrogen synthesis by inhibiting the aromatase enzyme, which converts androgens to estrogens in peripheral tissues. This reduction in estrogen levels leads to decreased activation of estrogen receptors (ER) and subsequent downregulation of estrogen-dependent signaling pathways, such as the MAPK and PI3K/Akt pathways, which are involved in cell proliferation and survival in hormone receptor-positive breast cancer and ovulation processes. The exact mechanisms of letrozole's effects on ovulation induction in polycystic ovary syndrome (PCOS) and its broader biological impacts are not fully understood.

Half-Life & Pharmacokinetics

POOral

Approximately 2 days

Letrozole is well absorbed orally with nearly complete bioavailability. It is primarily metabolized in the liver.

Storage

Temperature

Store at room temperature (15-30C)

Light

Protect from light

Form

Stable in tablet form for extended periods

Notes

Keep in a dry place and ensure the container is tightly closed.

Solubility

Löslichkeit

Letrozole is slightly soluble in water and highly soluble in organic solvents such as ethanol and methanol.

Legal Status

🇩🇪DE

Verschreibungspflichtig (prescription-only).

🇺🇸US

FDA approved for breast cancer treatment; prescription required.

🇦🇺AU

TGA Schedule 4 (prescription-only medicine).

🇬🇧UK

Prescription-only medicine (POM) as per MHRA classification.

Legal status information is provided for general reference only and may not reflect the most current regulatory changes. Always verify with official government sources before making any decisions.

Open Questions

Offene Forschungsfragen

Current evidence is limited regarding the optimal dosing protocols for letrozole in ovulation induction, particularly in comparing traditional versus stair-step approaches, necessitating larger randomized controlled trials to establish definitive protocols. Additionally, there is a lack of understanding about the predictors of resistance to letrozole in women with anovulation, highlighting the need for studies that explore biological and hormonal factors influencing treatment outcomes in diverse populations. Further research is needed to evaluate the long-term effects and safety of letrozole in various indications, including its use in premenopausal women and in the treatment of endometrial hyperplasia, to better inform clinical guidelines.

174 Research Publications

9,358

Total Citations

59

Human/RCT

10.5

Avg. Influence

2022

Latest

Sort
Filter
#01

Palbociclib and Letrozole in Advanced Breast Cancer.

Finn Richard S, et al. · The New England journal of medicine · 2016

HumanInfluence174.0
2538
The study demonstrated that palbociclib plus letrozole significantly improved progression-free survival compared to letrozole alone in postmenopausal women with ER-positive, HER2-negative advanced breast cancer.

Key findings

  1. 01Palbociclib plus letrozole increased progression-free survival to 24.8 months compared to 14.5 months with letrozole alone.
  2. 02Common serious side effects included low white blood cell counts and anemia in the palbociclib group.
  3. 039.7% of patients on palbociclib discontinued treatment due to side effects.
#02

The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study.

HumanInfluence82.0
1583
The study demonstrated that the addition of palbociclib to letrozole significantly improved progression-free survival in women with advanced ER-positive, HER2-negative breast cancer.
#03

Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.

Hortobagyi Gabriel N, et al. · The New England journal of medicine · 2022

HumanInfluence58.0
632
The study demonstrated that ribociclib plus letrozole significantly increased overall survival compared to placebo plus letrozole in postmenopausal patients with HR-positive, HER2-negative advanced breast cancer.

Key findings

  1. 01Ribociclib plus letrozole increased median overall survival to 63.9 months.
  2. 02The placebo group had a median overall survival of 51.4 months.
  3. 03No new safety concerns were identified with ribociclib treatment.
#04

Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer.

HumanInfluence23.0
499
The study demonstrated that sequential treatment with tamoxifen and letrozole does not improve disease-free survival compared to letrozole monotherapy in postmenopausal women with breast cancer.
#05

Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up.

Rugo H S, et al. · Breast cancer research and treatment · 2019

HumanInfluence31.0
406
Researchers observed that palbociclib plus letrozole significantly prolongs progression-free survival in women with estrogen receptor-positive advanced breast cancer compared to letrozole alone, confirming its efficacy as a first-line therapy.

Key findings

  1. 01Palbociclib plus letrozole improved progression-free survival to 27.6 months.
  2. 02The treatment delayed the need for chemotherapy compared to the placebo group.
  3. 03Safety and quality of life remained favorable for patients receiving palbociclib.
#06

A new era in ovulation induction.

ReviewInfluence13.0
222
Researchers observed that aromatase inhibitors, including letrozole, are effective for ovulation induction and superovulation, potentially replacing clomiphene citrate due to their favorable effects on the endometrium.
#07

Use of letrozole in assisted reproduction: a systematic review and meta-analysis.

Meta-AnalysisInfluence10.0
195
The systematic review indicated that letrozole is as effective as other ovulation induction methods, but further randomized-controlled studies are needed to clarify its efficacy and safety.
#08

The discovery and mechanism of action of letrozole.

ReviewInfluence4.0
184
Researchers observed that letrozole is a highly potent aromatase inhibitor that achieves near complete inhibition of estrogen production, demonstrating superior anti-tumor effects compared to other aromatase inhibitors and tamoxifen.
#09

Randomized Phase II Study Evaluating Palbociclib in Addition to Letrozole as Neoadjuvant Therapy in Estrogen Receptor-Positive Early Breast Cancer: PALLET Trial.

HumanInfluence15.0
182
The study demonstrated that adding palbociclib to letrozole significantly enhanced Ki-67 suppression in primary ER-positive breast cancer, though it did not improve clinical response rates over 14 weeks.
#10

Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer.

HumanInfluence9.0
179
Researchers observed that the combination of lapatinib and letrozole significantly improves progression-free survival and response rates in women with HER-2 positive metastatic breast cancer compared to letrozole alone.

Clinical Trials (247)

Preclinical
Phase I
Phase II
Phase III
Approved

247

Total Trials

73,341

Total Enrolled

Emulation of the MONARCH-3 Trial Using Specialty Oncology Electronic Health Records Databases

NCT07225790COMPLETED
Sponsor

Brigham and Women's Hospital

Enrollment

3,883

Started

2025

Primary outcome

Time to all-cause mortality (overall survival)

Advanced Breast Cancer

Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS

Sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Enrollment

1,078

Started

2022

Primary outcome

Live birth rate

PCOS

The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)

NCT06006091RECRUITING
Sponsor

International Peace Maternity and Child Health Hospital

Enrollment

858

Started

2023

Primary outcome

Live birth

LetrozoleInfertility, Female

Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy

NCT04176354COMPLETED
Sponsor

Pfizer

Enrollment

813

Started

2019

Primary outcome

Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method

Metastatic Breast Cancer

Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy

NCT04258163COMPLETED
Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

760

Started

2019

Primary outcome

Overall Survival (OS)

Metastatic Breast Cancer

FET in Adenomyosis

NCT06913075NOT_YET_RECRUITING
Sponsor

Indira IVF Hospital Pvt Ltd

Enrollment

700

Started

2026

Primary outcome

Ongoing pregnancy rate

Adenomyosis

The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

670

Started

2012

Primary outcome

ongoing pregnancy rate

Infertility

Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine

Sponsor

Heilongjiang University of Chinese Medicine

Enrollment

660

Started

2009

Primary outcome

Live-birth rate

Polycystic Ovary Syndrome

Effects of Adjuvant Endocrine Therapy With Aromatase Inhibitors on the Postoperative Lipid Levels in Postmenopausal Breast Cancer Patients

Sponsor

Chinese Academy of Medical Sciences

Enrollment

500

Started

2015

Primary outcome

Ratio of patients whose low density lipoprotein-cholesterol(LDL-C) level ≥ 4.14 mmol/L in 2 years of administration among groups

Breast Cancer

Letrozole Plus Misoprostol Versus Misoprostol Only in Induction of Missed Abortion

NCT07636317COMPLETED
Sponsor

Sohag University

Enrollment

400

Started

2025

Primary outcome

Incidence of bleeding

LetrozoleMisoprostolInductionMissed Abortion

Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.

NCT00956267COMPLETED
Sponsor

Mansoura University

Enrollment

260

Started

2006

Primary outcome

occurrence of ovulation and midcycle endometrial thickness (mm).

Polycystic Ovary Syndrome

A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer

Sponsor

The Affiliated Hospital of Qingdao University

Enrollment

200

Started

2024

Primary outcome

Progression-free survival(PFS)

Breast CancerNeoplasmsBreast Diseases

Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients

NCT02583828COMPLETED
Sponsor

Capital Medical University

Enrollment

200

Started

2015

Primary outcome

Progression free survival(PFS) of the subjects

Breast NeoplasmsNeoplasm Metastasis

Letrozole /GnRH Antagonist Protocol in Women Over 40 Years Undergoing ICSI Cycle

NCT05166668COMPLETED
Sponsor

Menoufia University

Enrollment

200

Started

2021

Primary outcome

live birth rate

Ovarian Stimulation

Comparison of 2 Ovarian Stimulation Protocols for Women With Low Ovarian Reserve

Sponsor

Sheba Medical Center

Enrollment

200

Started

2015

Primary outcome

Clinical pregnancy rates

Infertility

Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

NCT05487092RECRUITING
Sponsor

The University of Hong Kong

Enrollment

194

Started

2022

Primary outcome

Recurrence of endometrioma

Endometriotic Cyst of Ovary

the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women

NCT04619914COMPLETED
Sponsor

Laylay Mohammed Khalleefah Alhibshi

Enrollment

160

Started

2019

Primary outcome

the endometrial thickness

Endometrial ThicknessPregnancy Rate

Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

NCT06861803NOT_YET_RECRUITING
Sponsor

Al-Azhar University

Enrollment

138

Started

2025

Primary outcome

Comparison of baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Efficacy of Letrozole and CC Alone in an IUI Program in Cases With Surgically Treated Minimal to Mild Endometriosis

NCT01334762COMPLETED
Sponsor

Mansoura University

Enrollment

136

Started

2007

Primary outcome

Clinical pregnancy rate per cycle

Endometriosis

Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles

NCT06413771COMPLETED
Sponsor

Uludag University

Enrollment

131

Started

2023

Primary outcome

Clinical Pregnancy Rate

Infertility Unexplained

Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS

NCT06793904RECRUITING
Sponsor

Cairo University

Enrollment

122

Started

2025

Primary outcome

Number of participants with successful ovulation

Polycystic Ovarian Syndrome (PCOS)

FET-LET-2x2: Clinical Pregnancy Rates After Frozen Embryo Transfer in Natural and Modified Natural Cycles

NCT07425990RECRUITING
Sponsor

University of Novi Sad

Enrollment

120

Started

2026

Primary outcome

Clinical Pregnancy Rate

Infertility FemaleFrozen Embryo Transfer (FET)

The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

Sponsor

Assiut University

Enrollment

120

Started

2020

Primary outcome

determine efficacy of the aromatase inhibitor and Gnrh antagonist to achievement of resolution of ectopic pregnancy determined by serum hCG levels below laboratory immunoassay detection <15 IU/l.Results will be statistically analyzed,then evaluated .

Ectopic Pregnancy

Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors

NCT00111241COMPLETED
Sponsor

Monash University

Enrollment

115

Started

2005

Primary outcome

Knee Cartilage Volume

Arthralgia

Intrauterine Insemination With Letrozole Versus in Natural Cycle

NCT03455426COMPLETED
Sponsor

Peking University Third Hospital

Enrollment

100

Started

2018

Primary outcome

ongoing pregnancy

InfertilityIntrauterine Insemination

Cabergoline & Letrozole Versus Letrozole in Ovulation Induction in PCOS

NCT07255911RECRUITING
Sponsor

Mst.Sumyara Khatun

Enrollment

72

Started

2025

Primary outcome

Ovulation Rate

PCOS

Use of Aromatase Inhibitor Before Misoprostol in Medical Termination of Miscarriage

NCT07109947RECRUITING
Sponsor

Aswan University

Enrollment

70

Started

2025

Primary outcome

Miscarriage Achievement

Miscarriage

Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone

NCT05940233COMPLETED
Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Enrollment

70

Started

2023

Primary outcome

Rate of complete abortion

Medical; Abortion, Fetus

Reproductive Hormonal Alterations in Obesity

NCT01457703COMPLETED
Sponsor

University of Colorado, Denver

Enrollment

62

Started

2010

Primary outcome

Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)

Obesity

Magnesium Oxide and Letrozole Versus Letrozole Alone on Ovarian Response in Insulin Resistant PCOS

NCT07766590COMPLETED
Sponsor

Bangladesh Medical University

Enrollment

60

Started

2025

Primary outcome

Ovulation rate

Insulin Resistant PCOS

Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy

NCT06504082COMPLETED
Sponsor

Yuzuncu Yil University

Enrollment

60

Started

2021

Primary outcome

Decrease in β-hCG levels

Ectopic Pregnancy

Letrozole as a Treatment of Endometrial Cancer

NCT00997373COMPLETED
Sponsor

University of California, Davis

Enrollment

43

Started

2009

Primary outcome

Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer

Endometrial Carcinoma

Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

NCT00565240COMPLETED
Sponsor

University of Saskatchewan

Enrollment

41

Started

2007

Primary outcome

To evaluate differences in the mechanisms of atresia, initiation of a new synchronous follicular wave, interval to follicle wave emergence, interval to emergence of dominant follicle, interval to menstruation, and endometrial thickness/pattern.

Ovarian Follicle

Effects of Co-treatment on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure

NCT05437471COMPLETED
Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Enrollment

39

Started

2020

Primary outcome

endometrial abv3-integrin expression expressions

Miscarriage, Recurrent

A Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of TPBC

NCT06235931RECRUITING
Sponsor

Second Affiliated Hospital of Soochow University

Enrollment

34

Started

2024

Primary outcome

Progression Free Survival

Breast Neoplasms

Radiological and Biological Tumoural and Peri-tumoural Factors in Neoadjuvant Endocrine-treated Breast Cancers

NCT02701348COMPLETED
Sponsor

NHS Tayside

Enrollment

31

Started

2016

Primary outcome

Change in Proliferative response

Breast Cancer

Letrozole add-on in the Treatment of Cesarean Scar Pregnancy

NCT05839574COMPLETED
Sponsor

Jagiellonian University

Enrollment

28

Started

2021

Primary outcome

Blood loss during the procedure expressed as a decrease in hemoglobin concentration

Cesarean Scar Pregnancy

Bioequivalence Study of Letrozole 2.5 mg Tablets

NCT01084499COMPLETED
Sponsor

Yuhan Corporation

Enrollment

26

Started

2009

Primary outcome

Letrozole : AUC0-tz

Healthy

Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)

NCT07159880RECRUITING
Sponsor

GABRIEL MONTEIRO PINHEIRO

Enrollment

20

Started

2025

Primary outcome

Ovulation rate

PCOS (Polycystic Ovary Syndrome)InfertilityAnovulation

Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer.

NCT02010021COMPLETED
Sponsor

Dartmouth-Hitchcock Medical Center

Enrollment

17

Started

2014

Primary outcome

Change in Insulin Receptor Substrate 1 (IRS-1) / Phosphoinositide 3-kinase (PI3K) / Serine-threonine Protein Kinase (AKT) Pathway Activation

Breast Cancer

Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density

NCT00114270COMPLETED
Sponsor

University of Virginia

Started

2004

Breast CancerOsteoporosis

Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

NCT01127295Phase 4COMPLETED
Sponsor

Institut Claudius Regaud

Enrollment

2,000

Started

2010

Primary outcome

Correlation between pharmacokinetic and pharmacogenetic parameters

Hormono-depending Adjuvant Breast Cancer

Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy

NCT03220178Phase 4TERMINATED
Sponsor

Palleos Healthcare GmbH

Enrollment

532

Started

2017

Primary outcome

DQoL

Breast Neoplasm

Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer

NCT00688909Phase 4COMPLETED
Sponsor

Novartis Pharmaceuticals

Enrollment

261

Started

2008

Primary outcome

Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.

Breast Cancer

Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

NCT02679755Phase 4COMPLETED
Sponsor

Pfizer

Enrollment

252

Started

2016

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (All Causalities)

Breast Cancer

The Outcomes of ICSI Cycles With and Without Letrozole

NCT04159649Phase 4UNKNOWN
Sponsor

Mansoura University

Enrollment

224

Started

2019

Primary outcome

ongoing pregnancy rate.

EMBRYO IMPLANTATION

Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

NCT04217265Phase 4UNKNOWN
Sponsor

Cairo University

Enrollment

200

Started

2020

Primary outcome

complete abortion rate

Missed Abortion

Follicular Synchronization in PCOS Patients Undergoing ICSI

NCT04069117Phase 4COMPLETED
Sponsor

Mansoura University Hospital

Enrollment

200

Started

2019

Primary outcome

the number of asynchronized follicles in both groups

Polycystic Ovarian Syndrome

Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation

NCT05206448Phase 4ACTIVE_NOT_RECRUITING
Sponsor

Rachel Mejia

Enrollment

190

Started

2020

Primary outcome

Ovulation

Polycystic Ovary SyndromePCOSInfertility

Does The Addition Of Letrozole To Ultra-Long GnRH Agonists Help Adenomyosis Patients in ART? The AURA Trial

NCT06985186Phase 4NOT_YET_RECRUITING
Sponsor

University of Palermo

Enrollment

162

Started

2025

Primary outcome

Ongoing pregnancy rate

Adenomyosis of UterusInfertility Assisted Reproductive Technology

The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy

NCT05341817Phase 4RECRUITING
Sponsor

KK Women's and Children's Hospital

Enrollment

144

Started

2022

Primary outcome

Rate of complete abortion by Day 21-28

Abortion in First Trimester

A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study).

NCT03355157Phase 4COMPLETED
Sponsor

GBG Forschungs GmbH

Enrollment

130

Started

2018

Primary outcome

Time-to-treatment failure (TTF)

Metastatic Breast Cancer

Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

NCT00237133Phase 4COMPLETED
Sponsor

Novartis Pharmaceuticals

Enrollment

112

Started

2003

Primary outcome

Safety and tolerability of Letrozole

Locally Advanced Breast Cancer

Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer

NCT00171847Phase 4TERMINATED
Sponsor

Novartis Pharmaceuticals

Enrollment

93

Started

2003

Primary outcome

Time to progression as assessed by clinical palpation and radiologic imaging every 3 months

Metastatic Breast Cancer

Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer

NCT05183828Phase 4TERMINATED
Sponsor

University of Washington

Enrollment

62

Started

2022

Primary outcome

Changes in Ki67

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Breast AdenocarcinomaInvasive Breast Carcinoma of No Special Type

Dosage Optimization for Letrozole Treatment

NCT01315912Phase 4COMPLETED
Sponsor

Bushehr University of Medical Science

Enrollment

44

Started

2008

Primary outcome

normal follicular size

Infertility

Aromatase Inhibitor Effects on Ovarian Function During the Follicular and Early Luteal Phase in Women

NCT01046578Phase 4COMPLETED
Sponsor

University of Saskatchewan

Enrollment

41

Started

2010

Primary outcome

fate of the dominant follicle or luteal structure

Fertility

Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer

NCT01612871Phase 4COMPLETED
Sponsor

Institut Claudius Regaud

Enrollment

39

Started

2012

Primary outcome

Rates of patients for which specific tissular miRNAs are detected in blood before treatment (D0)

Breast Cancer

Influence of Aromatase Inhibition on Hepatic- and Cardiac Function in Severe Obese Men

NCT02097680Phase 4COMPLETED
Sponsor

University Hospital, Ghent

Enrollment

30

Started

2013

Primary outcome

cardiac function parameters

Obesity

Endometrial Preparation by Short Course of Letrozole Before Hysteroscopic Removal of Endocavitary Lesions

NCT04364581Phase 4UNKNOWN
Sponsor

Mansoura University

Enrollment

30

Started

2020

Primary outcome

Operative time

Myoma;Uterus

The Role of Estrogen in Luteinizing Hormone Surge and Ovulation

NCT01999569Phase 4COMPLETED
Sponsor

Wake Forest University Health Sciences

Enrollment

10

Started

2007

Primary outcome

Number of Participants With Progesterone Level Greater Than 1.5 ng/mL

Ovulation DisorderOvarian Cysts

A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial

NCT05205837Phase 4TERMINATED
Sponsor

Rigshospitalet, Denmark

Enrollment

8

Started

2021

Primary outcome

Change in plasma total testosterone concentration after 24 weeks from baseline

HypogonadismHypogonadism, MaleHypogonadotropic Hypogonadism

Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer

NCT00553410Phase 3COMPLETED
Sponsor

ETOP IBCSG Partners Foundation

Enrollment

4,884

Started

2007

Primary outcome

Disease-free Survival (DFS)

Breast Cancer

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

NCT05774951Phase 3RECRUITING
Sponsor

AstraZeneca

Enrollment

4,300

Started

2023

Primary outcome

Invasive breast cancer-free survival (IBCFS)

Breast Cancer, Early Breast Cancer

Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

NCT00382070Phase 3UNKNOWN
Sponsor

NSABP Foundation Inc

Enrollment

3,966

Started

2006

Primary outcome

Disease-free Survival

Breast Cancer

S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

NCT01674140Phase 3ACTIVE_NOT_RECRUITING
Sponsor

SWOG Cancer Research Network

Enrollment

1,939

Started

2013

Primary outcome

Invasive Disease-Free Survival (IDFS)

Breast Cancer

CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)

NCT07019363Phase 3RECRUITING
Sponsor

Fudan University

Enrollment

1,903

Started

2025

Primary outcome

5-years Invasive disease free survival

Breast CancerAdjuvant Therapy

HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.

NCT00412022Phase 3UNKNOWN
Sponsor

National Cancer Institute, Naples

Enrollment

1,294

Started

2004

Primary outcome

disease free survival in premenopausal patients

Breast Cancer

Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

NCT00073528Phase 3COMPLETED
Sponsor

Novartis Pharmaceuticals

Enrollment

1,286

Started

2003

Primary outcome

Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator

Breast Neoplasms

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

NCT06757634Phase 3RECRUITING
Sponsor

Celcuity Inc

Enrollment

1,180

Started

2025

Primary outcome

Progression Free Survival (PFS)

Breast Cancer

Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

NCT00171340Phase 3COMPLETED
Sponsor

Novartis Pharmaceuticals

Enrollment

1,065

Started

2003

Primary outcome

Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.

Bone LossBreast Cancer

Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

NCT06760637Phase 3ACTIVE_NOT_RECRUITING
Sponsor

Pfizer

Enrollment

1,035

Started

2025

Primary outcome

Progression Free Survival (PFS) by BICR

Breast Cancer

ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer

NCT04134598Phase 3ACTIVE_NOT_RECRUITING
Sponsor

Azienda Ospedaliero-Universitaria Careggi

Enrollment

926

Started

2021

Primary outcome

Patient reported outcome measures (PROM) HRQoL as assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30

Breast Cancer

Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

NCT06380751Phase 3RECRUITING
Sponsor

AstraZeneca

Enrollment

788

Started

2024

Primary outcome

Progression-Free Survival (Arm 1 vs arm 2)

Advanced Breast Cancer

Zoledronate in Preventing Bone Loss in Postmenopausal Women Who Are Receiving Letrozole for Stage I, Stage II, or Stage IIIA Breast Cancer

NCT00107263Phase 3COMPLETED
Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

558

Started

2005

Primary outcome

Average intra-patient change in total lumbar spine (L1-L4) bone mineral density (BMD) as measured by dual energy x-ray absorptiometry at baseline and 1 year after completion of study treatment

Breast CancerOsteoporosis

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

NCT02246621Phase 3ACTIVE_NOT_RECRUITING
Sponsor

Eli Lilly and Company

Enrollment

493

Started

2014

Primary outcome

Progression Free Survival (PFS)

Breast Cancer

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer

NCT02763566Phase 3ACTIVE_NOT_RECRUITING
Sponsor

Eli Lilly and Company

Enrollment

463

Started

2016

Primary outcome

Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)

Breast Cancer

Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT04095364Phase 3ACTIVE_NOT_RECRUITING
Sponsor

NRG Oncology

Enrollment

450

Started

2019

Primary outcome

Progression-free survival (PFS)

Low Grade Fallopian Tube Serous AdenocarcinomaOvarian Low Grade Serous AdenocarcinomaPrimary Peritoneal Low Grade Serous AdenocarcinomaStage II Fallopian Tube Cancer AJCC v8Stage II Ovarian Cancer AJCC v8Stage II Primary Peritoneal Cancer AJCC v8Stage III Fallopian Tube Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Primary Peritoneal Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8

This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.

NCT05439499Phase 3UNKNOWN
Sponsor

Ahon Pharmaceutical Co., Ltd.

Enrollment

434

Started

2022

Primary outcome

PFS is determined by IRC

Advanced Breast CancerFemale Breast Cancer

Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer

NCT04047758Phase 3UNKNOWN
Sponsor

Shengjing Hospital

Enrollment

420

Started

2019

Primary outcome

Progression-free survival

Breast Cancer

Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors

NCT01758146Phase 3UNKNOWN
Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Enrollment

412

Started

2012

Primary outcome

Disease free survival

Breast Cancer

Fulvestrant With or Without Lapatinib and/or Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer That Progressed After Previous Aromatase Inhibitor Therapy

NCT00688194Phase 3UNKNOWN
Sponsor

Gruppo Italiano Mammella (GIM)

Enrollment

396

Started

2008

Primary outcome

Progression-free survival

Breast Cancer

The Clinical Trial of Acupuncture Pre-treatment on PCOS

NCT02491320Phase 3COMPLETED
Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Enrollment

384

Started

2015

Primary outcome

Live birth rate

Polycystic Ovary Syndrome

Bevacizumab + Endocrine Treatment vs Endocrine Treatment as First Line in Postmenopausal Women

NCT00545077Phase 3COMPLETED
Sponsor

Spanish Breast Cancer Research Group

Enrollment

380

Started

2007

Primary outcome

Progression-free Survival (PFS)

Breast Cancer

Pre-Operative Window of ET to Inform RT Decisions (POWER II)

NCT06507618Phase 3RECRUITING
Sponsor

University of Virginia

Enrollment

354

Started

2024

Primary outcome

Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET)

Breast Cancer Female

A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer

NCT07340658Phase 3NOT_YET_RECRUITING
Sponsor

Rovi Pharmaceuticals Laboratories

Enrollment

300

Started

2026

Primary outcome

Progression Free Survival (PFS)

Advanced, Metastatic Breast Cancer

Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant

NCT03439046Phase 3TERMINATED
Sponsor

Novartis Pharmaceuticals

Enrollment

287

Started

2018

Primary outcome

Progression-Free Survival (PFS) by Cycle 1 Day 15 Complete Mutational Dynamic Change

Breast Cancer

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

NCT06072781Phase 3RECRUITING
Sponsor

Verastem, Inc.

Enrollment

270

Started

2024

Primary outcome

Progression Free Survival (PFS) per blinded independent central review (BICR)

Low Grade Serous Ovarian Cancer

A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer

NCT00171704Phase 3COMPLETED
Sponsor

Novartis Pharmaceuticals

Enrollment

263

Started

2005

Primary outcome

Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)

Hormone Sensitive Resected Primary Breast Cancer in Postmenopausal Women

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study

NCT05645536Phase 3ENROLLING_BY_INVITATION
Sponsor

Tolmar Inc.

Enrollment

250

Started

2022

Primary outcome

The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Breast Cancer

Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer

NCT02980965Phase 3COMPLETED
Sponsor

Fudan University

Enrollment

249

Started

2013

Primary outcome

objective response rate (ORR)

Breast Cancer Female

Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer

NCT04158362Phase 3ACTIVE_NOT_RECRUITING
Sponsor

UNICANCER

Enrollment

180

Started

2020

Primary outcome

Progression-free survival (PFS)

Cancer Metastatic

Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer

NCT00949598Phase 3COMPLETED
Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

177

Started

2008

Primary outcome

Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate

Breast Cancer

Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation

NCT00673335Phase 3COMPLETED
Sponsor

UNICANCER

Enrollment

170

Started

2008

Primary outcome

Survival without contralateral or unilateral invasive breast cancer at 5 years (prior breast cancer)

brca1 Mutation Carrierbrca2 Mutation CarrierBreast CancerHereditary Breast/Ovarian Cancer (brca1, brca2)

Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors.

NCT06244745Phase 3RECRUITING
Sponsor

IVI Madrid

Enrollment

152

Started

2023

Primary outcome

To determine ovarian volume in millilitres in oocyte donors according to whether or not they receive the treatment during the luteal phase after ovarian stimulation.

Luteinised Follicular Cyst

Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females

NCT06418347Phase 3UNKNOWN
Sponsor

Ain Shams University

Enrollment

150

Started

2024

Primary outcome

The primary outcome is cumulative ovulation rate

Polycystic Ovary SyndromeInfertility, Female

Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)

NCT05601700Phase 3RECRUITING
Sponsor

Ente Ospedaliero Ospedali Galliera

Enrollment

132

Started

2022

Primary outcome

Progression-free survival (PFS)

Carcinoma, Ovarian EpithelialLow Grade Serous Adenocarcinoma of Ovary

Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) Breast Cancer

NCT02769104Phase 3UNKNOWN
Sponsor

Zhejiang Cancer Hospital

Enrollment

120

Started

2016

Primary outcome

effective rate

Neoadjuvant Therapy

Letrozole Dose Increments in PCOS Patients Resistant to Letrozole

NCT06403488Phase 3COMPLETED
Sponsor

Beni-Suef University

Enrollment

102

Started

2023

Primary outcome

ovulation rate

Polycystic Ovary Syndrome

Myoinositol, L-arginine and Chromium With Letrozole for Ovulation Induction in Polycystic Ovarian Syndrome Patients

NCT06405243Phase 3UNKNOWN
Sponsor

Beni-Suef University

Enrollment

100

Started

2024

Primary outcome

ovulation

Polycystic Ovary Syndrome

Efficacy of Letrozole in Recurrent Ovarian Cancer

NCT04421547Phase 3TERMINATED
Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

86

Started

2020

Primary outcome

Proportion of patient alive at 12 months

Epithelial Ovarian Cancer

Letrozole Step up Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome

NCT07143682Phase 3COMPLETED
Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Enrollment

70

Started

2023

Primary outcome

The number of participants having mature follicle (mean diameter ≥18mm)

Polycystic Ovarian Syndrome (PCOS)Infertility

Short-term Effects of Aromatase Inhibition in Obese Men

NCT00138710Phase 3COMPLETED
Sponsor

Rijnstate Hospital

Enrollment

50

Started

2005

Primary outcome

Body weight

Hypogonadotrophic HypogonadismObesity

Effect of Letrozole on Seminal Parameters in Men With Non Obstructive Azoospermia and Severe Oligozoospermia.

NCT02900105Phase 3COMPLETED
Sponsor

KK Women's and Children's Hospital

Enrollment

28

Started

2015

Primary outcome

Sperm density

Azoospermia, NonobstructiveOligozoospermia

Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion

NCT02405156Phase 2/3COMPLETED
Sponsor

Ain Shams University

Enrollment

400

Started

2015

Primary outcome

Duration of induction of abortion

Miscarriage

Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification

NCT07319429Phase 2/3RECRUITING
Sponsor

Fudan University

Enrollment

260

Started

2026

Primary outcome

The complete response rate (CRR) at 32 weeks after initiating treatment.

Endometrial CancerFertility

Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients

NCT02221999Phase 2/3ACTIVE_NOT_RECRUITING
Sponsor

RenJi Hospital

Enrollment

250

Started

2013

Primary outcome

pathological complete remission rate

Tubular Breast CancerMucinous Breast CancerInvasive Ductal Breast CancerInflammatory Breast Cancer

Letrozole as a Prophylaxis From GTN for Complete Mole Patients

NCT05203562Phase 2/3UNKNOWN
Sponsor

Zagazig University

Enrollment

200

Started

2020

Primary outcome

(β-hCG) level

Gestational Trophoblastic Disease

Comparative Evaluation of the Efficacy of Letrozole, L-Carnitine, and Their Combination on Sperm Quality, Oxidative Stress, and ART Outcomes in Men With Idiopathic Oligoasthenoteratozoospermia.

NCT07669402Phase 2/3COMPLETED
Sponsor

Tehran University of Medical Sciences

Enrollment

90

Started

2023

Primary outcome

Sperm concentration (×10⁶/mL) after 3 months of treatment

Idiopathic OligoasthenoteratozoospermiaMale Infertility

Vitamin D and Calcium Supplementation in Breast Cancer

NCT05523609Phase 2/3UNKNOWN
Sponsor

Tanta University

Enrollment

40

Started

2022

Primary outcome

Osteocalcin level

Breast Cancer

Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment

NCT01797718Phase 2/3COMPLETED
Sponsor

Helsinki University Central Hospital

Enrollment

35

Started

2013

Primary outcome

testicular volume

Constitutional Delay of Growth and Puberty

Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer

NCT02692755Phase 2/3COMPLETED
Sponsor

Georgetown University

Enrollment

35

Started

2016

Primary outcome

Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event

Hormone Receptor Positive HER-2 Negative Breast Cancer

GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients

NCT06379113Phase 2/3RECRUITING
Sponsor

Xiaojun Chen

Enrollment

29

Started

2022

Primary outcome

Complete response rates within 28 weeks of treatment

Endometrial NeoplasmsAtypical Endometrial HyperplasiaProgesterone ResistanceObesity

Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

NCT00333047Phase 2/3COMPLETED
Sponsor

Novartis

Enrollment

24

Started

2002

Primary outcome

Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression

Metastatic Breast Cancer

Letrozole as Maintenance Therapy for Post-surgical Endometrial Cancer Patients With NSMP

NCT05454358Phase 2/3TERMINATED
Sponsor

Fudan University

Enrollment

12

Started

2022

Primary outcome

the 3-year Progression-Free-Survival(PFS)

Endometrial Cancer

Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation

NCT03285802Phase 2/3COMPLETED
Sponsor

Greater Baltimore Medical Center

Enrollment

1

Started

2017

Primary outcome

Single Arm Trial With Combination of Everolimus and Letrozole in Treatment With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation; Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria

Uterine Cancer

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

NCT01042379Phase 2RECRUITING
Sponsor

QuantumLeap Healthcare Collaborative

Enrollment

5,000

Started

2010

Primary outcome

Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.

Breast NeoplasmsBreast CancerBreast TumorsAngiosarcomaTNBC - Triple-Negative Breast CancerHER2-positive Breast CancerHER2-negative Breast CancerHormone Receptor Positive TumorHormone Receptor Negative TumorEarly-stage Breast CancerLocally Advanced Breast Cancer

Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study

NCT07581834Phase 2RECRUITING
Sponsor

Fujian Cancer Hospital

Enrollment

2,000

Started

2026

Primary outcome

3-year invasive disease-free survival

Breast DiseasesBreast NeoplasmsDalpiciclibEndocrine Breast DiseasesCDK4/6 InhibitorHR+/HER2- Breast Cancer

Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer

NCT02491983Phase 2COMPLETED
Sponsor

MedSIR

Enrollment

486

Started

2015

Primary outcome

1-year Progression Free Survival

Metastatic Breast Cancer

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

NCT03056755Phase 2COMPLETED
Sponsor

Novartis Pharmaceuticals

Enrollment

383

Started

2017

Primary outcome

Core Phase: Percentage of Participants Who Were Alive Without Disease Progression at 6 Months

Breast Cancer

Study of PF-07248144 in Advanced or Metastatic Solid Tumors

NCT04606446Phase 2RECRUITING
Sponsor

Pfizer

Enrollment

320

Started

2020

Primary outcome

Number of participants with dose-limiting toxicities in the Dose Escalation Arms.

Locally Advanced or Metastatic ER+ HER2- Breast CancerLocally Advanced or Metastatic Castration-resistant Prostate CancerLocally Advanced or Metastatic Non-small Cell Lung Cancer

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer

NCT02296801Phase 2COMPLETED
Sponsor

NSABP Foundation Inc

Enrollment

307

Started

2015

Primary outcome

Measurement of the Proliferation Marker Ki67 (% Positive Tumor Cells)

Breast CancerBreast CarcinomaBreast Tumors

A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)

NCT06979596Phase 2RECRUITING
Sponsor

Merck Sharp & Dohme LLC

Enrollment

250

Started

2025

Primary outcome

Progression-Free Survival (PFS) - All Cohorts

Malignant Neoplasm

Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+/HER2+ Advanced Breast Cancer

NCT07716046Phase 2NOT_YET_RECRUITING
Sponsor

Fudan University

Enrollment

240

Started

2026

Primary outcome

Progression-Free Survival (PFS) Assessed by Investigator

Breast CancerHER2-positive Breast CancerHormone Receptor-positive Breast CancerHR+/HER2+ Breast Cancer

Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer

NCT05638594Phase 2RECRUITING
Sponsor

Shengjing Hospital

Enrollment

236

Started

2022

Primary outcome

Pathologic Complete Response Rate (tpCR: ypT0-is/ypN0)

Breast Cancer

Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer

NCT03839823Phase 2COMPLETED
Sponsor

Novartis Pharmaceuticals

Enrollment

222

Started

2019

Primary outcome

Progression-free Survival

Breast Cancer

Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)

NCT04571437Phase 2UNKNOWN
Sponsor

Cairo University

Enrollment

204

Started

2020

Primary outcome

6 months Progression free survival rate

Breast CancerEstrogen Receptor-positive Breast CancerMetastatic Breast Cancer

A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.

NCT03906669Phase 2UNKNOWN
Sponsor

St Vincent's Hospital

Enrollment

200

Started

2018

Primary outcome

Geometric mean suppression of proliferation marker Ki67

Early-stage Breast CancerHormone Receptor Positive Tumor

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

NCT05467891Phase 2RECRUITING
Sponsor

Oana Danciu

Enrollment

200

Started

2022

Primary outcome

Recurrence Free Survival (RFS)

Locoregional RecurrenceHormone Receptor-positive Breast CancerHER2-negative Breast Cancer

A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer

NCT03306472Phase 2COMPLETED
Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrollment

198

Started

2017

Primary outcome

Determination of change in tumour proliferation measured by Ki67 immunohistochemical (IHC) assessment (%) at baseline compared to Day 15 (+ ≤4 days).

Breast Cancer

Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy

NCT00247650Phase 2COMPLETED
Sponsor

Novartis

Enrollment

190

Started

2005

Primary outcome

Clinical response at 24 weeks

Breast Cancer

Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy

NCT05979220Phase 2NOT_YET_RECRUITING
Sponsor

Shuangyue Liu

Enrollment

178

Started

2023

Primary outcome

Progression Free Survival (PFS)

Breast Cancer

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

NCT04931342Phase 2ACTIVE_NOT_RECRUITING
Sponsor

Hoffmann-La Roche

Enrollment

176

Started

2021

Primary outcome

Confirmed Objective Response Rate (ORR)

Ovarian Cancer

Bevacizumab Plus Paclitaxel Optimization Study With Interventional Aintenance Endocrine Therapy in Breast Cancer

NCT01989780Phase 2COMPLETED
Sponsor

Japan Breast Cancer Research Group

Enrollment

160

Started

2014

Primary outcome

Time to failure of strategy (TFS)

Metastatic Breast Cancer

Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

NCT00208273Phase 2COMPLETED
Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

150

Started

2005

Primary outcome

Sub-cutaneous late toxicity

Breast Cancer

Study of GnRH-A [Leuprorelin(Lorelin Depot] Plus Leterozole +/- Everolimus for Premenopausal Women With Metastatic Breast Cancer

NCT02344550Phase 2COMPLETED
Sponsor

Asan Medical Center

Enrollment

137

Started

2014

Primary outcome

Progression free survival (PFS)

Metastatic Breast Cancer

Extended High Dose Letrozole Regimen Versus Short Low Dose Letrozole Regimen as an Adjuvant to GnRH Antagonist Protocol in the Management of Poor Responders Undergoing IVF-ET

NCT01219153Phase 2COMPLETED
Sponsor

Cairo University

Enrollment

136

Started

2008

Primary outcome

Clinical pregnancy rate per started cycle

Infertility

Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer

NCT05463601Phase 2ACTIVE_NOT_RECRUITING
Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

132

Started

2022

Primary outcome

The incidence of grade ≥3 neutropenia at the end of cycle 1 (each cycle is 28 days)

Metastatic Breast Cancer

A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment With Focus on Mechanisms of Resistance to Endocrine Treatment (Fulvestrant/Aromatase Inhibitors) in Patients With Advanced Breast Cancer

NCT02958852Phase 2COMPLETED
Sponsor

Lund University Hospital

Enrollment

126

Started

2025

Primary outcome

Clinical benefit rate.

Breast Cancer

Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.

NCT07394946Phase 2NOT_YET_RECRUITING
Sponsor

Cancer Care Hospital & Research Centre Foundation, Lahore

Enrollment

126

Started

2026

Primary outcome

Extent of Axillary Nodal Pathologic Complete Response (pCR)

Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer

PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate

NCT03900637Phase 2ACTIVE_NOT_RECRUITING
Sponsor

Seoul National University Hospital

Enrollment

122

Started

2019

Primary outcome

Conversion Rate

Breast Cancer

Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

NCT02712723Phase 2ACTIVE_NOT_RECRUITING
Sponsor

Qamar Khan

Enrollment

121

Started

2016

Primary outcome

Rate of PEPI Score 0 at Surgery Between Ribociclib Containing Arms (Combined) vs. Letrozole Alone Arm.

Breast Cancer

A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause

NCT06465368Phase 2COMPLETED
Sponsor

Pfizer

Enrollment

121

Started

2024

Primary outcome

Percentage of Participants With Complete Cell Cycle Arrest (CCCA) at Day 14

Breast Cancer

NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial

NCT05569811Phase 2ACTIVE_NOT_RECRUITING
Sponsor

SOLTI Breast Cancer Research Group

Enrollment

120

Started

2022

Primary outcome

Rate of pCRBL (ypT0/is ypN0) at surgery

Breast Cancer

Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic

NCT00696072Phase 2COMPLETED
Sponsor

Bristol-Myers Squibb

Enrollment

120

Started

2008

Primary outcome

Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population

Metastatic Breast Cancer

Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer

NCT07285382Phase 2RECRUITING
Sponsor

wanghaibo

Enrollment

120

Started

2025

Primary outcome

Progression - Free Survival (PFS)

HR Positive HER2 Negative Advanced Breast Cancer

Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer

NCT03497702Phase 2UNKNOWN
Sponsor

National Cancer Center, Korea

Enrollment

114

Started

2017

Primary outcome

pathologic complete remission (pCR)

Breast CancerInvasive Breast Cancer

Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ

NCT01439711Phase 2COMPLETED
Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

108

Started

2012

Primary outcome

Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)

Breast Cancer

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer

NCT05247268Phase 2RECRUITING
Sponsor

Fudan University

Enrollment

104

Started

2022

Primary outcome

Complete response rates within 16 weeks of treatment

Endometrial Neoplasm Malignant Stage I

Combined Immunotherapies in Metastatic ER+ Breast Cancer

NCT04563507Phase 2RECRUITING
Sponsor

Weill Medical College of Cornell University

Enrollment

102

Started

2020

Primary outcome

Progression free survival (PFS) will be measured

Breast Cancer

Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer

NCT00416715Phase 2COMPLETED
Sponsor

University of Washington

Enrollment

100

Started

2006

Primary outcome

Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness

ArthralgiaMusculoskeletal ComplicationsPainRecurrent Breast CancerStage I Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer

A Study of Lerociclib in Participants With Advanced Breast Cancer

NCT05085002Phase 2TERMINATED
Sponsor

EQRx, Inc.

Enrollment

100

Started

2021

Primary outcome

Incidence of AEs and SAEs

Advanced Breast Cancer

Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer

NCT06650748Phase 2ENROLLING_BY_INVITATION
Sponsor

Peking University

Enrollment

100

Started

2025

Primary outcome

1. The proportion of (PEPI score 0 + pCR) in patients with discordant EPclin scores and Ki67 assessments who were randomly assigned to the "+CDK4/6i" group

Breast CancerEarly-stage Breast Cancer

A Study for Safety and Effectiveness of IMC-A12 by Itself or Combined With Antiestrogens to Treat Breast Cancer

NCT00728949Phase 2COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

93

Started

2008

Primary outcome

Progression-Free Survival (PFS)

Metastatic Breast Cancer

Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

NCT03633331Phase 2COMPLETED
Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

93

Started

2018

Primary outcome

Incidence of Adverse Events

Estrogen Receptor-positive Breast CancerHER2/Neu NegativeStage IV Breast Cancer AJCC v6 and v7

TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer

NCT06001762Phase 2ACTIVE_NOT_RECRUITING
Sponsor

Dana-Farber Cancer Institute

Enrollment

90

Started

2023

Primary outcome

Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 3 Months (12 Weeks)

Breast CancerEarly-stage Breast CancerHigh Risk Breast Carcinoma

Pyrotinib in Combination With Letrozole in Patients With HER2-Positive, ER-Positive Metastatic Breast Cancer

NCT04407988Phase 2UNKNOWN
Sponsor

Hunan Cancer Hospital

Enrollment

86

Started

2019

Primary outcome

Clinical Benefit rate (CBR)

Metastatic Breast Cancer

Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole

NCT05163106Phase 2COMPLETED
Sponsor

University Hospital, Akershus

Enrollment

85

Started

2022

Primary outcome

To study the change in levels of direct and indirect immunologic biomarkers of targeted cancer therapy with letrozole and ribociclib given in combination for patients with locally-advanced, ER-positive, HER-2 negative, luminal A7B breast cancer

Breast CancerHER2-negative Breast CancerER-positive Breast CancerLocally Advanced Breast CancerLuminal A Breast CancerLuminal B Breast Cancer

Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy

NCT06957379Phase 2ACTIVE_NOT_RECRUITING
Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Enrollment

78

Started

2024

Primary outcome

Objective Response Rate (ORR)

HR+/HER2- Advanced/Metastatic Breast Cancer

Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer

NCT00530868Phase 2COMPLETED
Sponsor

University of Alabama at Birmingham

Enrollment

75

Started

2007

Primary outcome

The Percentage of Participants With Pathologic Complete Response

Breast CancerCancer of the BreastBreast Neoplasm

Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram

NCT05847257Phase 2COMPLETED
Sponsor

Al-Mustansiriyah University

Enrollment

74

Started

2021

Primary outcome

The seminal fluid analysis

Male Reproductive ProblemInfertility, Male

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer

NCT02228681Phase 2COMPLETED
Sponsor

GOG Foundation

Enrollment

74

Started

2015

Primary outcome

Frequency of Response

Advanced, Persistent, or Recurrent Endometrial Cancer

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

NCT06348134Phase 2RECRUITING
Sponsor

University of Chicago

Enrollment

74

Started

2025

Primary outcome

Pathological Complete Response

Human Epidermal Growth Factor 2 Negative Carcinoma of BreastHER2-positive Breast CancerBreast Cancer

Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer

NCT06276868Phase 2RECRUITING
Sponsor

Henan Cancer Hospital

Enrollment

71

Started

2024

Primary outcome

pathologic complete response

Breast CancerHER2-positive Breast Cancer

Cyclophosphamide, Methotrexate, and Prednisolone With or Without Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer

NCT00687648Phase 2UNKNOWN
Sponsor

National Cancer Centre, Singapore

Enrollment

70

Started

2008

Primary outcome

Clinical benefit response rate (complete response, partial response, or stable disease for > 24 weeks)

Breast Cancer

Study of Efficacy, Safety, and Pharmacokinetics of FCN-437c in Combination With Fulvestrant or Letrozole+Goserelin

NCT05004142Phase 2UNKNOWN
Sponsor

Ahon Pharmaceutical Co., Ltd.

Enrollment

70

Started

2020

Primary outcome

Overall response rate

Breast Neoplasms

Neoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -

NCT03819010Phase 2COMPLETED
Sponsor

MedSIR

Enrollment

66

Started

2019

Primary outcome

Difference on Recurrence Score between pre and post-treatment (molecular results)

Breast Cancer

Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms

NCT01194440Phase 2COMPLETED
Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

63

Started

2011

Primary outcome

Number of Participants With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)

Ductal Carcinoma in SituEstrogen Receptor-positive Breast CancerProgesterone Receptor-positive Breast CancerStage I Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer

A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma

NCT01797523Phase 2COMPLETED
Sponsor

M.D. Anderson Cancer Center

Enrollment

62

Started

2013

Primary outcome

Clinical Benefit (CBR) Complete Response + Partial Response + Stable Disease Rates) Based on RECIST v1.1.

Endometrial Cancer

A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

NCT01684215Phase 2COMPLETED
Sponsor

Pfizer

Enrollment

61

Started

2012

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1

NeoplasmsBreast Neoplasms

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

NCT07054190Phase 2RECRUITING
Sponsor

Hoffmann-La Roche

Enrollment

60

Started

2025

Primary outcome

Percentage of Participants with Adverse Events (AEs)

Breast Cancer

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

NCT06179303Phase 2RECRUITING
Sponsor

University of Washington

Enrollment

60

Started

2024

Primary outcome

Response to abemaciclib + endocrine therapy

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Locally Advanced Unresectable HER2-Negative Breast CarcinomaLocally Advanced Unresectable Hormone Receptor-Positive Breast CarcinomaMetastatic HER2-Negative Breast CarcinomaMetastatic Hormone Receptor-Positive Breast Carcinoma

Letrozole and Imatinib Mesylate in Treating Postmenopausal Participants With Estrogen or Progesterone Positive Metastatic Breast Cancer

NCT00338728Phase 2COMPLETED
Sponsor

M.D. Anderson Cancer Center

Enrollment

59

Started

2003

Primary outcome

Objective Response Rate (ORR)

Anatomic Stage IV Breast Cancer AJCC v8Estrogen Receptor PositiveKIT PositivePDGFR PositivePostmenopausalProgesterone Receptor PositivePrognostic Stage IV Breast Cancer AJCC v8

Study of Breast Cancer Prevention by Letrozole in High Risk Women

NCT00579826Phase 2COMPLETED
Sponsor

Carol Fabian, MD

Enrollment

55

Started

2006

Primary outcome

Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months

Breast Cancer

Abemaciclib and Letrozole to Treat Endometrial Cancer

NCT04393285Phase 2ACTIVE_NOT_RECRUITING
Sponsor

Gynecologic Oncology Group

Enrollment

53

Started

2020

Primary outcome

Progression-free survival

Endometrial Cancer

Ribociclib and Letrozole Treatment in Ovarian Cancer

NCT03673124Phase 2ACTIVE_NOT_RECRUITING
Sponsor

Gynecologic Oncology Group

Enrollment

51

Started

2019

Primary outcome

Objective Response Rate (ORR)

Low Grade Serous Carcinoma

TRial on the Endocrine Activity of Neoadjuvant Degarelix

NCT02005887Phase 2COMPLETED
Sponsor

ETOP IBCSG Partners Foundation

Enrollment

51

Started

2014

Primary outcome

Time to Optimal Ovarian Function Suppression

Breast Cancer Invasive Nos

Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.

NCT00611715Phase 2TERMINATED
Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

48

Started

2003

Primary outcome

Number of Patients With Pathological Complete Response.

Breast Cancer

Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone

NCT02115048Phase 2TERMINATED
Sponsor

Translational Research in Oncology

Enrollment

44

Started

2014

Primary outcome

Progression Free Survival (PFS)

Breast Neoplasms

Bevacizumab and Letrozole in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer That Cannot Be Removed By Surgery

NCT00305825Phase 2COMPLETED
Sponsor

University of California, San Francisco

Enrollment

43

Started

2004

Primary outcome

Safety

Breast Cancer

Protocol for Women at Increased Risk of Developing Breast Cancer

NCT00291135Phase 2COMPLETED
Sponsor

Carol Fabian, MD

Enrollment

42

Started

2003

Primary outcome

Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.

Breast Cancer

Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole

NCT05286437Phase 2ACTIVE_NOT_RECRUITING
Sponsor

National Cancer Centre, Singapore

Enrollment

40

Started

2023

Primary outcome

Objective Response Rate (ORR) per RECIST version 1.1

Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer

Letrozole in Uterine Leiomyosarcoma

NCT05649956Phase 2RECRUITING
Sponsor

GOG Foundation

Enrollment

40

Started

2024

Primary outcome

Progression Free Survival

Uterine Leiomyosarcoma

Letrozole in the Treatment of Severe and Recurrent Endometriosis

NCT00240942Phase 2COMPLETED
Sponsor

Novartis Pharmaceuticals

Enrollment

40

Started

2002

Primary outcome

Response rates (CR, PR, NC, PD) during treatment of advanced endometrial cancer assessed by tumor marker assessments and radiologic imaging at week 12 then q 12 weeks x 1 year then q 16 weeks

Severe and Recurrent Endometriosis

A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer

NCT02742051Phase 2COMPLETED
Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

40

Started

2016

Primary outcome

Feasibility of the trial

Breast Cancer

Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer

NCT03219476Phase 2COMPLETED
Sponsor

Medical College of Wisconsin

Enrollment

37

Started

2017

Primary outcome

Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy.

Breast CancerInvasive Breast Cancer

A Study of Letrozole in the Treatment of Endometrial Cancer

NCT00333086Phase 2COMPLETED
Sponsor

Novartis Pharmaceuticals

Enrollment

36

Started

2000

Primary outcome

Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks

Recurrent and Metastatic Endometrial Cancer

Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer

NCT07795424Phase 2NOT_YET_RECRUITING
Sponsor

Shengjing Hospital

Enrollment

33

Started

2026

Primary outcome

Breast Pathological Complete Response Rate (bpCR)

Breast CancerHR Positive, HER2 Positive Breast Cancer

Letrozole, Herceptin in Her2neu +, Estrogen Receptor [ER] and/or Progesterone Receptor [PR] Positive, MBC

NCT00134680Phase 2COMPLETED
Sponsor

Duke University

Enrollment

33

Started

2000

Primary outcome

To determine the proportion of patients with ER and/or PR positive, ErbB2 positive tamoxifen resistant metastatic breast cancer who achieve complete remission (CR)

Metastatic Breast Cancer

ALPINE: Maintenance Letrozole/Abemaciclib

NCT06366347Phase 2RECRUITING
Sponsor

Dana-Farber Cancer Institute

Enrollment

32

Started

2024

Primary outcome

Median Progression Free Survival (PFS)

Endometrial CancerRecurrent Endometrial CancerTP53

Pyrotinib Combined With Trastuzumab,Dalpiciclib and Letrozole for HR+/HER2+ Breast Cancer

NCT05800756Phase 2UNKNOWN
Sponsor

Yantai Yuhuangding Hospital

Enrollment

30

Started

2022

Primary outcome

pathologic complete response

Breast Cancer

Letrozole Combined With Anlotinib Hydrochloride in the Treatment of Platinum-resistant Recurrent Ovarian Cancer

NCT04720807Phase 2UNKNOWN
Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

30

Started

2020

Primary outcome

ORR

Platinum-resistant Recurrent Ovarian Cancer

Open Label Trial for Post-Menopausal Women With Newly Diagnosed Operable Breast Cancer

NCT00161291Phase 2COMPLETED
Sponsor

University of Alabama at Birmingham

Enrollment

28

Started

2005

Primary outcome

The primary objective is to estimate the pathological complete response rate of neoadjuvant therapy in operable newly diagnosed ER+ breast cancer patients using the combination of Avastin and Letrozole.

Breast Cancer

Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer

NCT02907918Phase 2TERMINATED
Sponsor

Washington University School of Medicine

Enrollment

26

Started

2017

Primary outcome

Number of Participants With Pathologic Complete Response (pCR)

Breast CancerCancer of BreastBreast Carcinoma

RIOTC: Reducing the Impact of Ovarian Stimulation. Novel Approaches to Luteal Support in IVF-Study 2

NCT04524026Phase 2COMPLETED
Sponsor

Nicholas Macklon

Enrollment

25

Started

2018

Primary outcome

Length of luteal phase (days from aspiration untill bleeding)

IVF

A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)

NCT05035836Phase 2RECRUITING
Sponsor

M.D. Anderson Cancer Center

Enrollment

20

Started

2021

Primary outcome

To determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR

Breast CancerHER2-positive

Single Arm Trial With Combination of Everolimus and Letrozole in Treatment of Platinum Resistant Relapse or Refractory or Persistent Ovarian Cancer/Endometrial Cancer

NCT02188550Phase 2UNKNOWN
Sponsor

Sinai Hospital of Baltimore

Enrollment

20

Started

2014

Primary outcome

Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria

Ovarian CancerEndometrial Cancer

Letrozole for Lymphangioleiomyomatosis

NCT01353209Phase 2COMPLETED
Sponsor

University of Cincinnati

Enrollment

17

Started

2011

Primary outcome

Rate of Change in Forced Expiratory Volume in 1 Second in ml/Month

Lymphangioleiomyomatosis

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

NCT00903162Phase 2COMPLETED
Sponsor

Dana-Farber Cancer Institute

Enrollment

17

Started

2009

Primary outcome

Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.

Breast Cancer

Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

NCT00247663Phase 2COMPLETED
Sponsor

Novartis Pharmaceuticals

Enrollment

17

Started

1999

Primary outcome

Safety during treatment

Postmenopausal Women With Advanced Breast Cancer

Letrozole in Patients With Ovarian Tumors

NCT00505661Phase 2TERMINATED
Sponsor

M.D. Anderson Cancer Center

Enrollment

16

Started

2003

Primary outcome

Objective Response Rate Following Treatment With Letrozole

Ovarian CancerFallopian Tube CancerPeritoneal Cancer

A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)

NCT01919229Phase 2TERMINATED
Sponsor

Novartis Pharmaceuticals

Enrollment

14

Started

2013

Primary outcome

Cell Cycle Response Rate Per Cell Proliferation Marker Ki67

Early Breast Cancer

Trastuzumab and Letrozole in Treating Postmenopausal Women With Progressive Advanced Breast Cancer

NCT00238290Phase 2COMPLETED
Sponsor

Swiss Cancer Institute

Enrollment

13

Started

2005

Primary outcome

Objective response rate as assessed by CT scan or MRI every 3 months

Breast Cancer

Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in Combination for Stage II-III TPBC

NCT05228951Phase 2RECRUITING
Sponsor

Shengjing Hospital

Enrollment

12

Started

2022

Primary outcome

Total pathological complete response (tpCR)

Breast Cancer

Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer

NCT01499160Phase 2TERMINATED
Sponsor

University of Maryland, Baltimore

Enrollment

7

Started

2012

Primary outcome

Clinical Benefit Rate of Patients Treated With the Combination of Letrozole and Lapatinib and Then After Progression, Treated With Everolimus, Letrozole and Lapatinib.

Breast NeoplasmsEndocrine Breast DiseasesNeoplasm Metastasis

A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer

NCT00796107Phase 2TERMINATED
Sponsor

Hoffmann-La Roche

Enrollment

6

Started

2009

Primary outcome

Objective Tumor Response (Part 2)

Breast Cancer

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

NCT04256941Phase 2TERMINATED
Sponsor

M.D. Anderson Cancer Center

Enrollment

4

Started

2019

Primary outcome

Progression-free Survival (PFS)

Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaPrognostic Stage IV Breast Cancer AJCC v8

PTK and Letrozole in Post-menopausal Women With Advanced Breast Cancer

NCT00263198Phase 2TERMINATED
Sponsor

Washington University School of Medicine

Enrollment

4

Started

2006

Primary outcome

Assess the effect of the combination of letrozole & PTK787/ZK222584 on disease progression.

Breast Neoplasms

Phase II Study of Everolimus Beyond Progression

NCT02269670Phase 2TERMINATED
Sponsor

Emory University

Enrollment

3

Started

2014

Primary outcome

Response Rate (Partial Response Plus Complete Response) Using RECIST

Estrogen Receptor-positive Breast CancerHER2-negative Breast CancerProgesterone Receptor-positive Breast CancerRecurrent Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast Cancer

Letrozole in Patients With Hepatopulmonary Syndrome

NCT04577001Phase 2TERMINATED
Sponsor

Mayo Clinic

Enrollment

1

Started

2021

Primary outcome

Alveolar-Arterial Oxygen

Hepatopulmonary Syndrome

Letrozole and Goserelin or Leuprolide in Treating Premenopausal Estrogen Receptor-Positive Patients With Stage IV Breast Cancer

NCT00498901Phase 2TERMINATED
Sponsor

University of Washington

Enrollment

1

Started

2007

Primary outcome

Overall response rate as measured by RECIST

Breast Cancer

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

NCT03424005Phase 1/2RECRUITING
Sponsor

Hoffmann-La Roche

Enrollment

1,132

Started

2018

Primary outcome

Objective Response Rate (ORR)

Metastatic Breast Cancer

First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

NCT05768139Phase 1/2RECRUITING
Sponsor

Eli Lilly and Company

Enrollment

880

Started

2023

Primary outcome

Number of participants who experience at least 1 Dose Limiting Toxicity (DLT)

Breast CancerSolid Tumors, Adult

Study of AVZO-021 in Patients With Advanced Solid Tumors

NCT05867251Phase 1/2RECRUITING
Sponsor

Avenzo Therapeutics, Inc.

Enrollment

430

Started

2023

Primary outcome

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)

Advanced Solid TumorHR+/HER2- Breast CancerHR+, HER2-, Advanced Breast CancerCCNE1 AmplificationEpithelial Ovarian CancerPrimary Peritoneal CancerFallopian Tube CancerEndometrial CancerTNBC - Triple-Negative Breast Cancer

A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

NCT04539496Phase 1/2ACTIVE_NOT_RECRUITING
Sponsor

Sihuan Pharmaceutical Holdings Group Ltd.

Enrollment

402

Started

2018

Primary outcome

Single agent and combination dose exploration study:AE evaluation

Metastasis Solid TumorsAdvanced Breast Cancer

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

NCT01872260Phase 1/2ACTIVE_NOT_RECRUITING
Sponsor

Novartis Pharmaceuticals

Enrollment

255

Started

2013

Primary outcome

Incidence of Dose limiting toxicities (DLTs) - Phase lb only

Breast Cancer

A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors

NCT05262400Phase 1/2ACTIVE_NOT_RECRUITING
Sponsor

Pfizer

Enrollment

192

Started

2022

Primary outcome

Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle

Breast CancerSolid Tumors

A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer

NCT07389733Phase 1/2RECRUITING
Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

180

Started

2026

Primary outcome

Dose-limiting toxicity (DLT)

Advanced Unresectable or Metastatic Breast Cancer of Adults

Antagonist/Letrozole in Poor Responders

NCT00823004Phase 1/2COMPLETED
Sponsor

Yazd Research & Clinical Center for Infertility

Enrollment

120

Started

2008

Primary outcome

pregnancy rate

Ovarian Stimulation

Phase IB & II Study of Ribociclib With Trastuzumab Plus Letrozole in Postmenopausal HR+, HER2+ Advanced Breast Cancer Patients

NCT03913234Phase 1/2UNKNOWN
Sponsor

Yonsei University

Enrollment

95

Started

2019

Primary outcome

Progression free survival

HER2-positive Breast CancerPostmenopausalMetastatic Breast Cancer

A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer

NCT06974929Phase 1/2RECRUITING
Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

80

Started

2025

Primary outcome

Dose-limiting toxicity (DLT)

Breast Cancer

Study of XL147 (SAR245408) or XL765 (SAR245409) in Combination With Letrozole in Subjects With Breast Cancer

NCT01082068Phase 1/2COMPLETED
Sponsor

Sanofi

Enrollment

72

Started

2010

Primary outcome

Safety and tolerability of XL147 and letrozole and XL765 and letrozole

Breast Cancer

Study of Narazaciclib (ON 123300) Plus Letrozole in Endometrial Cancer and Other Gynecologic Malignancies

NCT05705505Phase 1/2UNKNOWN
Sponsor

Traws Pharma, Inc.

Enrollment

60

Started

2023

Primary outcome

Dose limiting toxicities (DLTs) will be tabulated and summarized by cohort

Endometrioid Endometrial Cancer

T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin

NCT01686828Phase 1/2COMPLETED
Sponsor

University of Washington

Enrollment

53

Started

2013

Primary outcome

Insulin Sensitivity Quantified by Matsuda Index

Insulin ResistanceType 2 Diabetes MellitusObesityAndrogen DeficiencyMetabolic Disease

Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer

NCT00634634Phase 1/2COMPLETED
Sponsor

Rutgers, The State University of New Jersey

Enrollment

52

Started

2008

Primary outcome

Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)

Metastatic Breast Cancer

Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer

NCT03054363Phase 1/2COMPLETED
Sponsor

University of Colorado, Denver

Enrollment

42

Started

2017

Primary outcome

Phase Ib Primary Outcome: Proportion of Patients Who Experienced DLTs Attributable to Palbociclib, Tucatinib, or Both

Breast Cancer

Letrozole Treatment in Normal and GnRH Deficient Women

NCT00351416Phase 1/2UNKNOWN
Sponsor

Massachusetts General Hospital

Enrollment

15

Started

2004

Primary outcome

FSH Level

Healthy Volunteers

Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

NCT04856371Phase 1UNKNOWN
Sponsor

Haihe Biopharma Co., Ltd.

Enrollment

228

Started

2021

Primary outcome

Dose Limiting Toxicities (DLT)

Advanced Breast Cancer

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

NCT02057133Phase 1ACTIVE_NOT_RECRUITING
Sponsor

Eli Lilly and Company

Enrollment

198

Started

2014

Primary outcome

Number of Participants with One or More Drug-Related Adverse Events

Breast Neoplasms

Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer

NCT07604571Phase 1RECRUITING
Sponsor

Novartis Pharmaceuticals

Enrollment

194

Started

2026

Primary outcome

Incidence and severity of dose-limiting toxicities (DLTs)

Advanced HR+/HER2- Breast Cancer

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

NCT02684032Phase 1COMPLETED
Sponsor

Celcuity Inc

Enrollment

141

Started

2016

Primary outcome

Number of participants with dose limiting toxicities

Breast Cancer

This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer

NCT03099174Phase 1COMPLETED
Sponsor

Boehringer Ingelheim

Enrollment

133

Started

2017

Primary outcome

[Cohort A, B, C & D] Maximum Tolerated Dose (MTD) of Xentuzumab

NeoplasmsBreast Neoplasms

A Study to Compare the Steady-State Bioavailability of Injectable Letrozole SIE and Oral Letrozole in Post-Menopausal Women With Hormone Receptor Positive Early Breast Cancer

NCT07401381Phase 1RECRUITING
Sponsor

Rovi Pharmaceuticals Laboratories

Enrollment

120

Started

2026

Primary outcome

Area under the concentration-time curve within a dosing interval at Steady-State (SS AUCtau)

Hormone Receptor Positive Early Breast Cancer

Phase I Study of BEBT-209 in Women With Advanced Breast Cancer

NCT06047184Phase 1UNKNOWN
Sponsor

BeBetter Med Inc

Enrollment

106

Started

2019

Primary outcome

MTD

Advanced Breast Cancer

A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer

NCT00960960Phase 1COMPLETED
Sponsor

Genentech, Inc.

Enrollment

71

Started

2009

Primary outcome

Percentage of Participants With Dose-Limiting Toxicities (DLTs)

Breast Cancer

BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer

NCT01870505Phase 1COMPLETED
Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

52

Started

2013

Primary outcome

Phase II Dose of BYL719/Alpelisib (Arm A and Arm B)

Metastatic or Locally-advanced Unresectable Breast Cancer

Food Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg

NCT00648154Phase 1COMPLETED
Sponsor

Mylan Pharmaceuticals Inc

Enrollment

24

Started

2005

Primary outcome

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.

Healthy

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

NCT06139107Phase 1RECRUITING
Sponsor

Mridula George, MD

Enrollment

15

Started

2024

Primary outcome

Safety and tolerability of the combination of abemaciclib and radiation as assessed by adverse events (AEs). Using Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Breast Cancer

Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer

NCT01199367Phase 1TERMINATED
Sponsor

Kyowa Kirin Co., Ltd.

Enrollment

11

Started

2010

Primary outcome

To establish the safety, tolerability, and recommended Phase 2 dose of KW-2450 administered in combination with lapatinib and letrozole in subjects with previously treated or untreated advanced breast cancer.

Breast Cancer

A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer

NCT05337657Phase 1UNKNOWN
Sponsor

Genor Biopharma Co., Ltd.

Enrollment

10

Started

2021

Primary outcome

DLT

Advanced Breast Cancer

Ovulation Induction in Clomiphene Citrate Resistant PCO Women

NCT02341703Early Phase 1COMPLETED
Sponsor

Cairo University

Enrollment

100

Started

2015

Primary outcome

ovulation rate

Polycystic Ovary SyndromeInfertility

Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA)

NCT02802748Early Phase 1COMPLETED
Sponsor

SOLTI Breast Cancer Research Group

Enrollment

60

Started

2016

Primary outcome

Changes in the expression of the PAM50 proliferation signature upon treatment in patients defined as Luminal by PAM50

Breast Cancer

Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer

NCT05464810Early Phase 1RECRUITING
Sponsor

Emory University

Enrollment

40

Started

2022

Primary outcome

Mean percentage change in Ki-67

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8HER2-Negative Breast CarcinomaHormone Receptor-Positive Breast CarcinomaInvasive Breast Carcinoma

A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer

NCT03962647Early Phase 1COMPLETED
Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

31

Started

2019

Primary outcome

Patients who complete the dietary intervention

Estrogen Receptor-positive Breast Cancer

IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC

NCT03378297Early Phase 1COMPLETED
Sponsor

Haukeland University Hospital

Enrollment

26

Started

2018

Primary outcome

Changes in the expression of biomarkers

Ovarian Cancer

A Window-of-opportunity Study of Pelareorep in Early Breast Cancer

NCT04102618Early Phase 1TERMINATED
Sponsor

Oncolytics Biotech

Enrollment

26

Started

2019

Primary outcome

To evaluate if pelareorep in combination with different therapies increases the value of the CelTIL score in women with operable early breast cancer. CelTIL is a combined IHC-based score based on tumor cellularity and stromal TILs.

Breast Cancer

Evaluating the Pharmacokinetics and Drug Interaction Potential of the Botanical Dietary Supplement Cinnamon

NCT05157672Early Phase 1UNKNOWN
Sponsor

Washington State University

Enrollment

16

Started

2021

Primary outcome

Nicotine area under the concentration vs. time curve (AUC) ratio (exposure/baseline)

Interaction Drug Food

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