Hormone · Profile

Anastrozole

Arimidex · AI · Aromatase Inhibitor

Hormone ManagementApproved

MW: 293.4g/mol
Formula: C17H19N5

Anastrozole is a third-generation aromatase inhibitor that originates from the class of non-steroidal compounds designed to inhibit estrogen synthesis, primarily acting in peripheral tissues such as adipose tissue. Researchers primarily study anastrozole for its efficacy in the adjuvant treatment of hormone receptor-positive breast cancer in postmenopausal women. Key findings from pivotal studies, such as the ATAC trial, indicate that anastrozole significantly prolongs disease-free survival and reduces the risk of recurrence compared to tamoxifen, with a more favorable side-effect profile. Clinical evidence suggests that anastrozole is now considered the preferred initial treatment option for this patient population, particularly due to its improved tolerability. Ongoing research continues to explore its applications and effectiveness in various settings, reinforcing its relevance in contemporary oncology.

Overview

Übersicht

Anastrozole is a synthetic compound classified as a third-generation aromatase inhibitor. It is not endogenously produced but is chemically synthesized for therapeutic use. Anastrozole is primarily used in the management of hormone receptor-positive breast cancer, particularly in postmenopausal women. Researchers have found that anastrozole plays a crucial role in reducing estrogen levels, thereby inhibiting the growth of estrogen-dependent tumors. It is also being explored for its potential in treating conditions like idiopathic short stature in pubertal boys. The mechanism of action of anastrozole involves the inhibition of the aromatase enzyme, which is responsible for the conversion of androgens to estrogens. This inhibition leads to a significant reduction in circulating estrogen levels, disrupting the growth of estrogen-dependent cancer cells. Pharmacokinetically, anastrozole is well-absorbed orally, with a half-life of approximately 50 hours, allowing for once-daily dosing. It is extensively metabolized in the liver, primarily via N-dealkylation, hydroxylation, and glucuronidation. Clinically, anastrozole is approved for use as an adjuvant treatment in hormone receptor-positive breast cancer and has shown superior efficacy and tolerability compared to tamoxifen in several studies. It is widely recognized by regulatory agencies such as the FDA and EMA for its role in breast cancer management.

Chemical profile

Chemische Struktur

Formel	C17H19N5
Molekulargewicht	293.4g/mol
CAS-Nummer	120511-73-1
PubChem CID	2187

Mechanism

Wirkmechanismus

Anastrozole acts by inhibiting the aromatase enzyme, which converts androgens into estrogens. This action leads to a decrease in estrogen levels, thereby reducing the growth stimulus for estrogen receptor-positive breast cancer cells.

Mechanism

Signalweg

Anastrozole is a selective aromatase inhibitor that blocks the aromatase enzyme, which is responsible for converting androgens (androstenedione and testosterone) into estrogens (estrone and estradiol) in postmenopausal women. By reducing estrogen levels, anastrozole decreases estrogen receptor signaling in hormone receptor-positive breast cancer cells, thereby inhibiting tumor growth and proliferation through pathways such as the estrogen receptor signaling pathway. The precise molecular mechanisms underlying its effects on tumor biology are still being investigated.

Half-Life & Pharmacokinetics

POOral

Approximately 50 hours

Anastrozole is primarily metabolized in the liver and has a high oral bioavailability.

Storage

Temperature

Store at room temperature (15-30C)

Light

Protect from light

Form

Stable in tablet form

Notes

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

Solubility

Löslichkeit

Anastrozole is poorly soluble in water but soluble in organic solvents like ethanol.

Legal Status

🇩🇪DE

Verschreibungspflichtig (prescription only), not listed as a controlled substance under BtMG.

🇺🇸US

FDA approved for breast cancer treatment, prescription required.

🇦🇺AU

TGA classified as Schedule 4 (prescription only medicine).

🇬🇧UK

Prescription only medicine (POM) under MHRA regulations.

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 long-term safety profile of anastrozole, particularly concerning its effects on bone health and the incidence of fractures in diverse populations, including younger postmenopausal women and those with varying comorbidities. Further research is needed to explore the comparative effectiveness of anastrozole versus other aromatase inhibitors in specific subgroups, such as those with a history of thromboembolic events or different genetic backgrounds. Additionally, larger randomized controlled trials are required to assess the potential benefits of anastrozole in combination therapies, especially in settings beyond breast cancer, such as its use in idiopathic short stature in pubertal boys.

186 Research Publications

14,486

Total Citations

Human/RCT

5.8

Avg. Influence

2025

Latest

Sort

Filter

01Top

#01

Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer.

Howell A, et al. · Lancet (London, England)

HumanInfluence82.0

2360

Researchers observed that anastrozole significantly improved disease-free survival and reduced recurrence rates compared to tamoxifen in postmenopausal women with localized hormone-receptor-positive breast cancer.

Key findings

01Anastrozole led to fewer cancer recurrences than tamoxifen.
02Patients on anastrozole experienced fewer side effects, particularly gynecological issues.
03Anastrozole reduced the occurrence of distant metastases and contralateral breast cancers.

PubMed

02Top

#02

Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial.

Cuzick Jack, et al. · The Lancet. Oncology · 2010

HumanInfluence38.0

1549

Researchers observed that anastrozole provided superior long-term disease-free survival and lower recurrence rates compared to tamoxifen in postmenopausal women with early-stage breast cancer over a 10-year follow-up.

Key findings

01Anastrozole improved disease-free survival compared to tamoxifen.
02Patients on anastrozole had longer times before cancer recurrence.
03Serious side effects were less common with anastrozole than tamoxifen.

PubMed

03Top

#03

Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group.

HumanInfluence17.0

1009

Researchers observed that anastrozole provides a significant increase in time to progression compared to tamoxifen in postmenopausal women with advanced breast cancer, with fewer adverse events.

PubMed

#04

Anastrozole versus tamoxifen as first-line therapy for advanced breast cancer in 668 postmenopausal women: results of the Tamoxifen or Arimidex Randomized Group Efficacy and Tolerability study.

HumanInfluence17.0

868

Researchers observed that anastrozole is at least equivalent to tamoxifen in efficacy for advanced breast cancer while exhibiting a lower incidence of thromboembolic events and vaginal bleeding.

PubMed

#05

Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study.

HumanInfluence40.0

853

Researchers observed that trastuzumab combined with anastrozole significantly improves progression-free survival compared to anastrozole alone in postmenopausal women with HER2-positive metastatic breast cancer.

PubMed

#06

Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: the Immediate Preoperative Anastrozole, Tamoxifen, or Combined with Tamoxifen (IMPACT) multicenter double-blind randomized trial.

HumanInfluence34.0

760

PubMed

#07

Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study.

HumanInfluence20.0

715

The study demonstrated that the 21-gene recurrence score is an independent predictor of distant recurrence in postmenopausal patients treated with anastrozole or tamoxifen for breast cancer.

PubMed

#08

Relationship between quantitative estrogen and progesterone receptor expression and human epidermal growth factor receptor 2 (HER-2) status with recurrence in the Arimidex, Tamoxifen, Alone or in Combination trial.

HumanInfluence2.0

438

Researchers observed that quantitative expression of estrogen and progesterone receptors did not identify patients who would benefit differentially from anastrozole compared to tamoxifen in terms of time to recurrence.

PubMed

#09

Anastrozole, a potent and selective aromatase inhibitor, versus megestrol acetate in postmenopausal women with advanced breast cancer: results of overview analysis of two phase III trials. Arimidex Study Group.

HumanInfluence4.0

404

Researchers observed that anastrozole is well tolerated and as effective as megestrol acetate in postmenopausal women with advanced breast cancer who progressed after tamoxifen treatment.

PubMed

#10

Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative "Arimidex" Compared to Tamoxifen (PROACT) trial.

HumanInfluence8.0

364

The study demonstrated that anastrozole is an effective preoperative therapy for postmenopausal women with hormone receptor-positive breast cancer, leading to clinically beneficial tumor downstaging.

PubMed

Clinical Trials (160)

Preclinical

Phase I

Phase II

Phase III

Approved

160

Total Trials

80,617

Total Enrolled

Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.

NCT06086340COMPLETED

Sponsor

Pfizer

Enrollment

779

Started

2023

Primary outcome

Overall Survival According to Unadjusted Analysis

Breast Cancer

Comparative Evaluation of Efficacy and Safety of Toremifene, Tamoxifen, and Aromatase Inhibitor Plus Ovarian Function Suppression in Hormone Receptor-Positive Early Breast Cancer Among Non-Low-Risk Premenopausal Women: A Real-World Study

NCT05801705UNKNOWN

Sponsor

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

Enrollment

700

Started

2023

Primary outcome

disease free survival

Hormone-receptor-positive Breast CancerPremenopausal Breast CancerBreast Cancer Patients at Intermediate to High RiskOvarian Function Suppression Combined With Aromatase Inhibitor or Tamoxifen or Torimefen

Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

NCT06905301RECRUITING

Sponsor

Novartis Pharmaceuticals

Enrollment

240

Started

2026

Primary outcome

Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period

Breast Cancer

Cardiovascular Outcomes of Low Testosterone

NCT02758431COMPLETED

Sponsor

University of Colorado, Denver

Enrollment

232

Started

2016

Primary outcome

Endothelial function

Hypogonadism

Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer

NCT00562458COMPLETED

Sponsor

AstraZeneca

Enrollment

200

Started

2006

Advanced Breast Cancer

Breast Cancer Tumor Care Observational Programme

NCT00660244COMPLETED

Sponsor

AstraZeneca

Enrollment

150

Started

2008

Primary outcome

Progression of disease and tolerability in general

Post MenopausalArthralgia

Regulation of Cortisol Metabolism and Fat Patterning

NCT00694733UNKNOWN

Sponsor

Oregon Health and Science University

Enrollment

140

Started

2005

Primary outcome

To measure 24-hour CPR, free cortisol, and cortisol binding globulin levels in plasma; HSD 1 activity, glucocorticoid receptor binding, and cortisol levels in adipocytes; and urinary excretion of cortisol, cortisone and their metabolites.

ObesityMenopausal Syndrome

Efficacy and Safety of Leuprorelin 3M in Premenopausal Women With Hormone Receptor-positive Breast Cancer

NCT04891731UNKNOWN

Sponsor

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

Enrollment

120

Started

2021

Primary outcome

the suppression proportion of serum estradiol (E2)

Hormone Receptor-positive Breast Cancer

Arimidex Therapy Compliance Electronic Monitoring System

NCT00936442COMPLETED

Sponsor

AstraZeneca

Enrollment

104

Started

2009

Primary outcome

Overall adherence to anastrozole

Breast Cancer

CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)

NCT00973505UNKNOWN

Sponsor

Korea University Anam Hospital

Enrollment

100

Started

2009

Primary outcome

Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level

Breast NeoplasmsArthralgiaArthritisGenetic Polymorphism

Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging

NCT05700006COMPLETED

Sponsor

University of Michigan

Enrollment

Started

2022

Primary outcome

Percentage of particpants in the 65+ AI therapy group who complete 3 serial blood collections and 5 serial ePRO collections

Breast Neoplasm FemaleArthralgiaAging

Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy

NCT00681928COMPLETED

Sponsor

City of Hope Medical Center

Enrollment

Started

2007

Primary outcome

Impact of treatment with an aromatase inhibitor on cognitive function

Breast Cancer

Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy

NCT01016665COMPLETED

Sponsor

Federal University of São Paulo

Enrollment

Started

2005

Primary outcome

Expression of progesterone

Breast Cancer

Bone Geometry and Muscle Density Changes in Postmenopausal Women and Breast Cancer Patients Prescribed Anastrozole

NCT00421447COMPLETED

Sponsor

Hamilton Health Sciences Corporation

Enrollment

Started

2007

Breast Cancer

The Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans

NCT07212712NOT_YET_RECRUITING

Sponsor

University of British Columbia

Enrollment

Started

2026

Primary outcome

Cerebral blood flow responses to estrogen and testosterone

Cerebral Blood FlowCerebral Blood Flow RegulationSex DifferencesExerciseVascular

GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients

NCT02095184TERMINATED

Sponsor

University of Maryland, Baltimore

Enrollment

Started

2015

Primary outcome

Percent Change in Proliferative Index (Ki67) After Treatment With the Standard Dose Anastrozole or Letrozole in Normal, Obese, and Overweight Patients

Breast Cancer

H (Trastuzumab or Biosimilar) Combined With CDK4/6 Inhibitor + AI±OFS in the Treatment of HR+HER2+ Advanced Breast Cancer Efficacy and Safety: a Chinese Multi-center Real World Study

NCT05167643UNKNOWN

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

Started

2022

Primary outcome

Progression-free survival (PFS)

Advanced HR+ HER2 Negative Breast Carcinoma

Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions

NCT01155102COMPLETED

Sponsor

Roxane Laboratories

Enrollment

Started

2006

Primary outcome

bioequivalence determined by statistical comparison Cmax

Breast Cancer

Aromatase Inhibitor in Bone Maturation, Children With Silver Russell or Prader-Willi Syndrome

NCT01520467UNKNOWN

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

Started

2012

Primary outcome

The rate of success in each of the two groups, evaluated using an X-ray of the left hand and wrist. Success is defined as a difference in the rate of progression of bone maturation of at least 9 months after 18 months of treatment.

Silver Russell SyndromePrader-Willi Syndrome

Pre-Surgical Intervention for Targeted Therapies for Breast Cancer

NCT01004744COMPLETED

Sponsor

Columbia University

Enrollment

Started

2007

Primary outcome

Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery

Invasive Breast Cancer

Liver Safety Under Upfront Arimidex vs Tamoxifen

NCT00537771Phase 4COMPLETED

Sponsor

AstraZeneca

Enrollment

384

Started

2007

Primary outcome

Incidence of Fatty Liver Disease

Breast Cancer

Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

NCT03421639Phase 4UNKNOWN

Sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

Enrollment

300

Started

2017

Primary outcome

pregnancy after embryo transfer

Uterine AdenomyosisRecurrent Implantation FailureMenstrual Pain

Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer

NCT00082277Phase 4COMPLETED

Sponsor

AstraZeneca

Enrollment

237

Started

2004

Primary outcome

The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)

Breast Cancer

A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

NCT04707196Phase 4COMPLETED

Sponsor

Eli Lilly and Company

Enrollment

200

Started

2021

Primary outcome

Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event

Breast NeoplasmsNeoplasm Metastasis

Arthralgia During Anastrozole Therapy for Breast Cancer

NCT00323479Phase 4COMPLETED

Sponsor

AstraZeneca

Enrollment

114

Started

2006

Primary outcome

Number of Participants With New Events of Arthralgia

Early Breast Cancer

STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)

NCT00126360Phase 4UNKNOWN

Sponsor

St George Hospital, Australia

Enrollment

100

Started

2005

Primary outcome

Local failure within irradiation volume

Breast Cancer

Brain Blood Flow Responses to Stress: Sex Differences

NCT06253702Phase 4COMPLETED

Sponsor

University of Wisconsin, Madison

Enrollment

Started

2024

Primary outcome

Cerebral Blow Flow (CBF): Hormone Suppression Hypoxia Condition

Cerebrovascular Disorders

Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis

NCT00286351Phase 4COMPLETED

Sponsor

Rigshospitalet, Denmark

Enrollment

Started

2005

Primary outcome

size of endometriomas after 2½ month of combined downregulation

Endometriosis

A Prospective,Open-label Study of Anastrozole in Post-menopausal Women With Hormone Sensitive Advanced Breast Cancer

NCT00544986Phase 4COMPLETED

Sponsor

AstraZeneca

Started

2005

Primary outcome

1. Tolerability(safety) 2.Efficacy (a) Time to tumor progression TTP (b) Objective Response (OR) Rate (c) Symptom Evaluation

Breast Cancer

ATAC - Arimidex, Tamoxifen Alone or in Combination

NCT00849030Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

9,358

Started

1996

Primary outcome

Time to recurrence of breast cancer

Breast Cancer

ATAC - Pharmacokinetics (PK) Sub-Protocol

NCT00784862Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

9,358

Started

1998

Primary outcome

Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole

Breast Cancer

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

NCT05952557Phase 3ACTIVE_NOT_RECRUITING

Sponsor

AstraZeneca

Enrollment

5,511

Started

2023

Primary outcome

Invasive breast cancer-free survival (IBCFS)

Breast Cancer, Early Breast Cancer

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

NCT01272037Phase 3ACTIVE_NOT_RECRUITING

Sponsor

National Cancer Institute (NCI)

Enrollment

5,018

Started

2011

Primary outcome

Invasive Disease-Free Survival (IDFS)

Breast Ductal Carcinoma In SituInvasive Breast CarcinomaMulticentric Breast CarcinomaMultifocal Breast CarcinomaSynchronous Bilateral Breast Carcinoma

Trial of Perioperative Endocrine Therapy - Individualising Care

NCT02338310Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

4,486

Started

2008

Primary outcome

Time to recurrence

Breast Cancer

Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer

NCT00078832Phase 3COMPLETED

Sponsor

Queen Mary University of London

Enrollment

3,864

Started

2003

Primary outcome

Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years

Breast Cancer

ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.

NCT00291759Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

3,858

Started

1996

Primary outcome

To assess the difference in event free survival and overall survival (subject to stand-alone or combined/meta-analysis) between postmenopausal women with HR +ve early BC who switched from tamoxifen to anastrozole and those who continued on tamoxifen.

Breast Cancer

Secondary Adjuvant Long Term Study With Arimidex

NCT00295620Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

3,484

Started

2004

Primary outcome

Disease-free Survival After Prolonged Endocrine Treatment

Breast Cancer

Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy

NCT00556374Phase 3COMPLETED

Sponsor

Amgen

Enrollment

3,420

Started

2006

Primary outcome

Time to First Clinical Fracture

Breast Cancer

STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)

NCT00887380Phase 3UNKNOWN

Sponsor

Trans Tasman Radiation Oncology Group

Enrollment

2,023

Started

2009

Primary outcome

To determine if commencement of anastrozole prior to radiotherapy results in improved local control compared to anastrozole commenced after radiotherapy.

Breast Cancer

Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer

NCT00301457Phase 3COMPLETED

Sponsor

Maastricht University Medical Center

Enrollment

1,914

Started

2006

Primary outcome

To assess the disease free survival (DFS) with 6 years of adjuvant anastrozole compared with 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of adjuvant tamoxifen

Breast Cancer

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

NCT00295646Phase 3COMPLETED

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Enrollment

1,803

Started

1999

Primary outcome

Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)

Breast Cancer

Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery

NCT01953588Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

1,473

Started

2014

Primary outcome

Rate of endocrine resistant disease-(First Phase)

Estrogen Receptor-positive Breast CancerHER2-negative Breast CancerInvasive Ductal Breast CarcinomaInvasive Lobular Breast CarcinomaRecurrent Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer

Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole

NCT00543127Phase 3TERMINATED

Sponsor

Spanish Breast Cancer Research Group

Enrollment

870

Started

2007

Primary outcome

Disease Free Survival (DFS) Events

Breast Cancer

Study of Faslodex +/- Concomitant Arimidex v Exemestane Following Progression on Non-steroidal Aromatase Inhibitors

NCT00253422Phase 3COMPLETED

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

698

Started

2004

Primary outcome

Progression-free Survival

Breast Cancer

S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer

NCT00075764Phase 3COMPLETED

Sponsor

SWOG Cancer Research Network

Enrollment

695

Started

2004

Primary outcome

Time to Tumor Progression

Breast Cancer

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

NCT02278120Phase 3COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

672

Started

2014

Primary outcome

Progression Free Survival (PFS) by Investigator Assessment

Advanced Metastatic Breast Cancer

Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

NCT00265759Phase 3COMPLETED

Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

622

Started

2006

Primary outcome

Clinical Response (Complete or Partial Response) Rate (Cohort A)

Breast Cancer

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

NCT02947685Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Alliance Foundation Trials, LLC.

Enrollment

518

Started

2017

Primary outcome

Progression-free Survival (PFS) as Assessed by Investigator

HER-2 Positive Breast CancerEstrogen Receptor Positive Breast Cancer

Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

NCT00256698Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

514

Started

2004

Primary outcome

Time to Progression (TTP)

Breast Cancer

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

NCT06016738Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Olema Pharmaceuticals, Inc.

Enrollment

510

Started

2023

Primary outcome

Dose-Selection Part: Incidence of adverse events

Breast CancerAdvanced Breast CancerMetastatic Breast CancerER Positive Breast CancerHER2 Negative Breast Carcinoma

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.

NCT01602380Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

462

Started

2012

Primary outcome

Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole

Hormone Receptor Positive Breast Cancer

Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy

NCT07400523Phase 3NOT_YET_RECRUITING

Sponsor

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

Enrollment

446

Started

2026

Primary outcome

3-year invasive disease-free survival

Breast Cancer

A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

NCT03966898Phase 3UNKNOWN

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

426

Started

2019

Primary outcome

Investigator-assessed PFS

Advanced Breast Cancer

A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer

NCT05257395Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Xuanzhu Biopharmaceutical Co., Ltd.

Enrollment

397

Started

2022

Primary outcome

Investigator-assessed progression free survival (PFS)

Advanced Breast Cancer

A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer

NCT01160211Phase 3COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

369

Started

2011

Primary outcome

Progression Free Survival (PFS) Events in Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) vs. Trastuzumab + Aromatase Inhibitor (AI)

Neoplasms, Breast

ATAC - Quality of Life Sub-Protocol

NCT00784680Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

308

Started

1998

Primary outcome

Time to withdrawal

Quality of Life

Detect V / CHEVENDO (Chemo vs. Endo)

NCT02344472Phase 3UNKNOWN

Sponsor

Prof. Wolfgang Janni

Enrollment

271

Started

2015

Primary outcome

Number of Participants with Adverse Events

Metastatic Breast Cancer

Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer

NCT02767661Phase 3COMPLETED

Sponsor

Sun Yat-sen University

Enrollment

263

Started

2017

Primary outcome

Progress-free survival

Breast Cancer

Faslodex Advanced Breast Cancer Local Chinese Study

NCT00327769Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

234

Started

2005

Primary outcome

Time to Disease Progression (TTP)

Advanced Breast Cancer

Study of Arimidex and Radiotherapy Sequencing

NCT01402193Phase 3UNKNOWN

Sponsor

Fudan University

Enrollment

220

Started

2011

Primary outcome

Level of TGF-β1

Breast Cancer

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)

NCT05512364Phase 3RECRUITING

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

220

Started

2023

Primary outcome

Distant metastasis free survival (DMFS)

ER-positive Breast CancerHER2-negative Breast CancerStage IIB Breast CancerStage III Breast Cancer

A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer

NCT00022672Phase 3COMPLETED

Sponsor

Hoffmann-La Roche

Enrollment

208

Started

2001

Primary outcome

Progression Free Survival (PFS)

Breast Cancer

Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer

NCT06447623Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Fudan University

Enrollment

184

Started

2024

Primary outcome

Progression Free Survival (PFS)

Advanced Breast CancerHR+/HER2- Breast Cancer

Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients

NCT02511639Phase 3COMPLETED

Sponsor

Istituto Oncologico Veneto IRCCS

Enrollment

110

Started

2014

Primary outcome

Progression free survival

Breast Cancer Metastatic

A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

NCT02730091Phase 3TERMINATED

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrollment

Started

2016

Primary outcome

progression-free survival (PFS)

Breast Cancer

Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer

NCT00893061Phase 3COMPLETED

Sponsor

Centre Oscar Lambret

Enrollment

Started

2009

Primary outcome

Changes in verbal episodic memory performance after 6 months of treatment, using the Rey Auditory Verbal Learning Test

Breast Cancer

S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer

NCT02137837Phase 3TERMINATED

Sponsor

SWOG Cancer Research Network

Enrollment

Started

2014

Primary outcome

Progression-Free Survival (Fulvestrant vs Fulvestrant + Everolimus )

Breast Cancer

Aromatase Inhibitors in the Treatment of Male Infertility

NCT00440180Phase 3TERMINATED

Sponsor

University of Utah

Enrollment

Started

2007

Primary outcome

Pregnancy Rate

ObesityOligospermia

Gynecomastia Extension Study

NCT00637182Phase 3COMPLETED

Sponsor

AstraZeneca

Started

2001

Primary outcome

Change in linear dimensions of the breast

Gynecomastia

Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer

NCT00053911Phase 3TERMINATED

Sponsor

UNICANCER

Started

2002

Primary outcome

Evaluation of the disease free survival

Breast Cancer

Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

NCT00133354Phase 2/3COMPLETED

Sponsor

Nemours Children's Clinic

Enrollment

Started

2001

Primary outcome

The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.

Hypopituitarism

Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole

NCT00077168Phase 2UNKNOWN

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

2,000

Started

2004

Primary outcome

Local tumor control (invasive and in situ local recurrence)

Breast Cancer

Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk

NCT05297617Phase 2RECRUITING

Sponsor

UNICANCER

Enrollment

696

Started

2022

Primary outcome

Distant relapse-free interval (DRFI)

Breast Cancer

Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer

NCT01151215Phase 2TERMINATED

Sponsor

AstraZeneca

Enrollment

482

Started

2010

Primary outcome

Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

NeoplasmsBreast NeoplasmsBreast Cancer

Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

NCT03822468Phase 2COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

376

Started

2019

Primary outcome

Overall Response Rate (ORR)

Breast Cancer

Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.

NCT03671330Phase 2COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

327

Started

2018

Primary outcome

Pre and Postmenopausal Cohorts: Progressive Free Survival (PFS) Based on Local Assessment by RECIST 1.1 Guideline

Breast Cancer

Bay98-7196, Dose Finding / POC Study

NCT02203331Phase 2COMPLETED

Sponsor

Bayer

Enrollment

319

Started

2014

Primary outcome

Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD

Endometriosis

Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer

NCT05949541Phase 2RECRUITING

Sponsor

Fudan University

Enrollment

265

Started

2023

Primary outcome

Progression Free Survival (PFS)

Breast CancerAdvanced Breast Cancer

A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer

NCT01491737Phase 2COMPLETED

Sponsor

Hoffmann-La Roche

Enrollment

258

Started

2012

Primary outcome

Progression-Free Survival (PFS)

Breast Cancer

Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive/ HR Positive MBC

NCT03910712Phase 2UNKNOWN

Sponsor

Peking Union Medical College Hospital

Enrollment

250

Started

2019

Primary outcome

Progression-Free Survival (PFS)

Breast Cancer FemaleHER2-positive Breast CancerHormone Receptor Positive Malignant Neoplasm of BreastMetastatic Breast CancerBreast DiseasesHormone Receptor Positive Tumor

Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer

NCT00437359Phase 2TERMINATED

Sponsor

Japan Breast Cancer Research Network

Enrollment

240

Started

2007

Primary outcome

Recurrence-free rate

Breast Neoplasms

A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer

NCT05896566Phase 2COMPLETED

Sponsor

ETOP IBCSG Partners Foundation

Enrollment

231

Started

2024

Primary outcome

Change in Ki 67

Breast Cancer

A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer

NCT00274469Phase 2COMPLETED

Sponsor

AstraZeneca

Enrollment

205

Started

2006

Primary outcome

Clinical Benefit Rate

Metastatic Breast Cancer

Endocrine Response in Women With Invasive Lobular Breast Cancer

NCT02206984Phase 2COMPLETED

Sponsor

Priscilla McAuliffe

Enrollment

201

Started

2015

Primary outcome

Change in Log-transformed Ki67 Proliferative Index

Breast Cancer

Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)

NCT06656624Phase 2RECRUITING

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

190

Started

2024

Primary outcome

Progression Free Survival

Advanced Breast Cancer

The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer

NCT02072512Phase 2UNKNOWN

Sponsor

Hospital Affiliated to Military Medical Science, Beijing

Enrollment

180

Started

2014

Primary outcome

the efficacy of goserelin plus fulvestrant 500mg and the efficacy of goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer in terms of progression-free survival(PFS)

Metastatic Breast Cancer

Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer

NCT02040857Phase 2COMPLETED

Sponsor

Dana-Farber Cancer Institute

Enrollment

162

Started

2014

Primary outcome

2-Year Treatment Discontinuation Rate

Breast Cancer

A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery

NCT05549505Phase 2COMPLETED

Sponsor

Arvinas Inc.

Enrollment

152

Started

2023

Primary outcome

Percent Reduction in Ki-67 Expression From Baseline to Day 15 in Tumor Biopsies

Breast Cancer

Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer

NCT00057941Phase 2COMPLETED

Sponsor

National Cancer Institute (NCI)

Enrollment

148

Started

2003

Primary outcome

Clinical Benefit Rate

Estrogen Receptor-positive Breast CancerProgesterone Receptor-positive Breast CancerRecurrent Breast CancerStage IV Breast Cancer

Fulvestrant (F)/Goserelin (G) vs Anastrozole (A)/G vs G for Premenopausal Women

NCT01266213Phase 2UNKNOWN

Sponsor

Samsung Medical Center

Enrollment

147

Started

2010

Primary outcome

Time to Progression (TTP)

Metastatic Breast CancerEstrogen Receptor Positive TumorBreast Cancer Nos Premenopausal

Capecitabine in Combination With Aromatase Inhibitor Versus Aromatase Inhibitors, in Hormonal Receptor Positive Recurrent or Metastatic Breast Cancer Patients, Randomized Controlled Study

NCT04012918Phase 2UNKNOWN

Sponsor

Ain Shams University

Enrollment

124

Started

2018

Primary outcome

Progress-free survival

Metastatic Breast Cancer

Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

NCT00871858Phase 2COMPLETED

Sponsor

Institut Bergonié

Enrollment

120

Started

2008

Primary outcome

Objective Response Rate (ORR) Determined by Clinical Palpation

Breast Cancer

Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer

NCT00629616Phase 2COMPLETED

Sponsor

UNICANCER

Enrollment

116

Started

2007

Primary outcome

Clinical tumor response as assessed by RECIST criteria

Breast Cancer

FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer

NCT03944434Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Fondazione Sandro Pitigliani

Enrollment

116

Started

2018

Primary outcome

Treatment feasibility

Breast Cancer

Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer

NCT06361940Phase 2RECRUITING

Sponsor

Medical College of Wisconsin

Enrollment

100

Started

2024

Primary outcome

Change from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors.

Breast Cancer

Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer

NCT01924078Phase 2UNKNOWN

Sponsor

Fudan University

Enrollment

100

Started

2010

Primary outcome

adverse events

Breast Cancer

Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer

NCT07616427Phase 2RECRUITING

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Enrollment

100

Started

2026

Primary outcome

Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0

HR+/HER2+ Early Breast Cancer

Anastrozole Administration in Elderly Hypogonadal Men

NCT00136695Phase 2COMPLETED

Sponsor

Massachusetts General Hospital

Enrollment

Started

2004

Primary outcome

Change in Lean Body Mass

Hypogonadism

Pulmonary Hypertension and Anastrozole Trial

NCT03229499Phase 2COMPLETED

Sponsor

University of Pennsylvania

Enrollment

Started

2017

Primary outcome

Change in Six-minute Walk Distance

Pulmonary Arterial Hypertension

PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer

NCT01723774Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Washington University School of Medicine

Enrollment

Started

2013

Primary outcome

Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 (PIK3CA Wild Type Cohort Only)

Breast Neoplasms

NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer

NCT05837455Phase 2RECRUITING

Sponsor

Washington University School of Medicine

Enrollment

Started

2024

Primary outcome

Objective response rate (ORR) by breast MRI in the combined low-risk plus high-risk endocrine-sensitive groups (pooled endocrine therapy-responders)

Breast CancerCancer of the Breast

Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive， Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer

NCT07796880Phase 2NOT_YET_RECRUITING

Sponsor

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

Enrollment

Started

2026

Primary outcome

Rate of participants achieving Residual Cancer Burden (RCB) grade 0 or 1

Hormone Receptor-Positive Breast CancerHER2 Low Breast CarcinomaEarly-Stage Breast Cancer

Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer

NCT00405938Phase 2COMPLETED

Sponsor

SCRI Development Innovations, LLC

Enrollment

Started

2006

Primary outcome

Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

Breast CancerBreast Neoplasms

Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer

NCT04088110Phase 2UNKNOWN

Sponsor

Fuzhou General Hospital

Enrollment

Started

2019

Primary outcome

Progression-Free Survival (PFS)

Breast Cancer FemaleHER2-positive Breast CancerHormone Receptor Positive Malignant Neoplasm of BreastMetastatic Breast CancerBreast DiseasesHormone Receptor Positive Tumor

Evaluation of ATRA Activity in Combination With Anastrozole in Pre-operative Phase of Operable Early Breast Cancer

NCT04113863Phase 2TERMINATED

Sponsor

Mario Negri Institute for Pharmacological Research

Enrollment

Started

2019

Primary outcome

Responders

Breast Neoplasm Female

Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer

NCT00066378Phase 2COMPLETED

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

Started

2003

Primary outcome

Progression-free survival at 1 year

Breast Cancer

Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

NCT00555477Phase 2TERMINATED

Sponsor

University of Michigan Rogel Cancer Center

Enrollment

Started

2007

Primary outcome

The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy

Breast Cancer

Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers

NCT00467493Phase 2COMPLETED

Sponsor

Meditrina Pharmaceuticals

Enrollment

Started

2007

Primary outcome

Endometrial thickness as measured by transvaginal ultrasound, safety

Menstruation Disorders

ETHAN - ET for Male BC

NCT05501704Phase 2RECRUITING

Sponsor

Jose Pablo Leone

Enrollment

Started

2023

Primary outcome

Change in Ki-67

Male Breast CancerHormone Receptor-positive Breast CancerHormone Receptor Negative Breast Carcinoma

Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer

NCT02910050Phase 2UNKNOWN

Sponsor

Xu fei

Enrollment

Started

2016

Primary outcome

clinical benefit rate（CBR）

Breast Cancer

Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex

NCT00235937Phase 2COMPLETED

Sponsor

AstraZeneca

Enrollment

Started

2001

Primary outcome

Determine the feasibility and efficacy of the combination of these 2 drugs in these patients

Breast Cancer

Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer

NCT02213042Phase 2TERMINATED

Sponsor

Novartis Pharmaceuticals

Enrollment

Started

2014

Primary outcome

Fold Change in Expression Profile of Genes and/or Proteins for Arm A (LAP+TRAS±AI (HER2-Enriched)) From Screening to Approx. 3.5 Years

Neoplasms, Breast

QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant Chemotherapy

NCT07782840Phase 2NOT_YET_RECRUITING

Sponsor

Hebei Medical University Fourth Hospital

Enrollment

Started

2026

Primary outcome

Objective Response Rate (ORR)

Breast Cancer

Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo

NCT00179517Phase 2COMPLETED

Sponsor

Beth Israel Deaconess Medical Center

Enrollment

Started

2001

Primary outcome

Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.

Seizure DisorderHypogonadismErectile Dysfunction

Evaluation of Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic Low Grade Endometrial Stromal Sarcoma (LGESS)

NCT03624244Phase 2RECRUITING

Sponsor

Centre Leon Berard

Enrollment

Started

2019

Primary outcome

Progression free survival

Low Grade Endometrial Stromal Sarcoma

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing

NCT06145308Phase 2RECRUITING

Sponsor

Peking Union Medical College

Enrollment

Started

2023

Primary outcome

ORR

Salivary Gland CarcinomaPrecision Therapy

A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER+/HER2+ Breast Cancer.

NCT04236310Phase 2UNKNOWN

Sponsor

Ruijin Hospital

Enrollment

Started

2020

Primary outcome

Ki67 changes from baseline to 2 weeks after the start of the neoadjuvant therapy

Breast CancerHER2-positive Breast CancerER-positive Breast Cancer

Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer

NCT00181688Phase 2COMPLETED

Sponsor

Massachusetts General Hospital

Enrollment

Started

2003

Primary outcome

To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.

Ovarian CancerPeritoneal CarcinomaTubal Carcinoma

Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women

NCT00186121Phase 2COMPLETED

Sponsor

Stanford University

Enrollment

Started

2000

Primary outcome

Objective Response Rate (ORR)

Breast Cancer

A Study of Onapristone ER Alone Or In Combination With Anastrozole in Gynecologic Cancers That Respond to Progesterone

NCT03909152Phase 2COMPLETED

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

Started

2019

Primary outcome

Overall Response Rate

Granulosa Cell Ovarian CancerLow Grade Serous Ovarian/ Primary Peritoneal CancerEndometrioid Endometrial Cancer

Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7)

NCT04227327Phase 2TERMINATED

Sponsor

University of Milano Bicocca

Enrollment

Started

2020

Primary outcome

Clinical benefit rate (CBR) in HD-FUL pre-treated MBC patients treated with Abemaciclib + aromatase inhibitors (letrozole or anastrozole)

Advanced Breast Cancer

Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER)

NCT05640778Phase 2UNKNOWN

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

Started

2022

Primary outcome

Complete cell cycle arrest（CCCA, defined as ki67≤2.7%）rate at 2 weeks of treatment

Luminal B/HER2-negative Breast Cancer

Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer

NCT02648477Phase 2COMPLETED

Sponsor

City of Hope Medical Center

Enrollment

Started

2016

Primary outcome

Number of Participants With Overall Response

Estrogen Receptor NegativeEstrogen Receptor PositiveHER2/Neu NegativeProgesterone Receptor NegativeProgesterone Receptor PositiveStage IV Breast CancerTriple-Negative Breast Carcinoma

Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer

NCT00005908Phase 2COMPLETED

Sponsor

National Cancer Institute (NCI)

Enrollment

Started

2000

Primary outcome

Number of Participants With Adverse Events

Breast CancerBreast Neoplasm

Study of the Effect of the Addition of SNDX-275 (Entinostat) to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing

NCT00828854Phase 2COMPLETED

Sponsor

Syndax Pharmaceuticals

Enrollment

Started

2008

Primary outcome

Clinical Benefit Rate (CBR)

ER+ Breast Cancer

A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer

NCT04075604Phase 2COMPLETED

Sponsor

Bristol-Myers Squibb

Enrollment

Started

2019

Primary outcome

The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase

Breast CancerCancer

Anastrozole in Patients With Pulmonary Arterial Hypertension

NCT01545336Phase 2COMPLETED

Sponsor

University of Pennsylvania

Enrollment

Started

2012

Primary outcome

Plasma Estradiol (E2) Level

Pulmonary Arterial Hypertension

Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer

NCT01776008Phase 2TERMINATED

Sponsor

National Cancer Institute (NCI)

Enrollment

Started

2013

Primary outcome

Pathological Complete Response Rate

Estrogen Receptor PositiveHER2/Neu NegativeRecurrent Breast CarcinomaStage IIA Breast CancerStage IIB Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer

Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy

NCT00661531Phase 2TERMINATED

Sponsor

Georgetown University

Enrollment

Started

2008

Primary outcome

Progression Free Survival

Breast CancerCancer of the BreastNeoplasms, Breast

Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors

NCT02592083Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Thomas Hatschek

Enrollment

Started

2015

Primary outcome

Clinical and Radiological Response

Early-Stage Breast CarcinomaHormone Receptor Positive Tumor

NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer

NCT02689921Phase 2UNKNOWN

Sponsor

Midwestern Regional Medical Center

Enrollment

Started

2016

Primary outcome

Evidence of Pathological Response

Breast Neoplasms

Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery

NCT01234532Phase 2TERMINATED

Sponsor

University of Maryland, Baltimore

Enrollment

Started

2010

Primary outcome

Recommended Phase II Dose of Entinostat in Combination With Anastrozole (Pilot)

Estrogen Receptor-negative Breast CancerHER2-negative Breast CancerProgesterone Receptor-negative Breast CancerStage I Breast CancerStage II Breast CancerStage IIIA Breast CancerTriple-negative Breast Cancer

Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer

NCT00303615Phase 2TERMINATED

Sponsor

Legacy Health System

Enrollment

Started

2005

Primary outcome

Time to disease progression

Metastatic Breast Cancer

1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.

NCT02000596Phase 2TERMINATED

Sponsor

University of Maryland, Baltimore

Enrollment

Started

2014

Primary outcome

Overall Response Rate (ORR) in Patients

Metastatic Breast Cancer

Phase 2 Anastrozole and Vandetanib (ZD6474) in Neoadjuvant Treatment of Postmenopausal Hormone Receptor-Positive Breast Cancer

NCT00481845Phase 2TERMINATED

Sponsor

Stanford University

Enrollment

Started

2008

Primary outcome

Tumor Objective Response by MRI

Breast Cancer

Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer

NCT00049062Phase 2COMPLETED

Sponsor

The University of Texas Health Science Center at San Antonio

Started

2002

Breast Cancer

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

NCT00004900Phase 2COMPLETED

Sponsor

Hackensack Meridian Health

Started

1999

Breast Cancer

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

NCT00004906Phase 2COMPLETED

Sponsor

Hackensack Meridian Health

Started

1999

Breast Cancer

BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder

NCT07596212Phase 1/2NOT_YET_RECRUITING

Sponsor

University of Illinois at Chicago

Enrollment

100

Started

2026

Primary outcome

Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder

Early-stage Breast CancerHypoactive Sexual Desire DisorderHormone Receptor Positive Breast CarcinomaBreast Cancer

Hormone Receptor Positive endometrIal Carcinoma Treated by Dual mTORC1/mTORC2 Inhibitor and Anastrozole (VICTORIA)

NCT02730923Phase 1/2UNKNOWN

Sponsor

Centre Leon Berard

Enrollment

Started

2016

Primary outcome

Number of patients with severe toxicities occurring during the first 8 weeks of follow-up assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) V4

Endometrial CarcinomaMetastatic CarcinomaHormone Receptor Positive Tumor

A Pharmacokinetic and Randomized Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer

NCT01216176Phase 1/2COMPLETED

Sponsor

Joyce Marie Slingerland, MD

Enrollment

Started

2008

Primary outcome

Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole

Breast Cancer

AZD4547 & Anastrozole or Letrozole (NSAIs) in ER+ Breast Cancer Patients Who Have Progressed on NSAIs (RADICAL)

NCT01791985Phase 1/2COMPLETED

Sponsor

Imperial College London

Enrollment

Started

2012

Primary outcome

Number of Participants With Serious Adverse Events (SAEs)

Breast Cancer

Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast

NCT03304080Phase 1/2ACTIVE_NOT_RECRUITING

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

Started

2017

Primary outcome

Dose-Limiting Toxicity (DLT)

Breast NeoplasmsBreast Diseases

Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.

NCT03616587Phase 1ACTIVE_NOT_RECRUITING

Sponsor

AstraZeneca

Enrollment

396

Started

2018

Primary outcome

The number of subjects with dose-limiting toxicity, as defined in the protocol.

ER+ HER2- Advanced Breast Cancer

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

NCT04188548Phase 1ACTIVE_NOT_RECRUITING

Sponsor

Eli Lilly and Company

Enrollment

379

Started

2019

Primary outcome

Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities

Breast CancerAdvanced Breast CancerMetastatic Breast CancerEndometrial Cancer

A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

NCT04556773Phase 1ACTIVE_NOT_RECRUITING

Sponsor

AstraZeneca

Enrollment

138

Started

2020

Primary outcome

Occurrence of adverse events (AEs)- Part 1

Metastatic Breast Cancer

Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

NCT00438321Phase 1TERMINATED

Sponsor

Massachusetts General Hospital

Enrollment

Started

2006

Primary outcome

Insulin sensitivity

Metabolic Syndrome

Effect of Concomitant Use of an Antimycotic, an Antibiotic, a Spermicide or Tampons on Pharmacokinetics of Anastrozole and Levonorgestrel Released From Intra-vaginal Ring

NCT02545452Phase 1COMPLETED

Sponsor

Bayer

Enrollment

Started

2015

Primary outcome

Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups

Endometriosis

Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

NCT06218303Phase 1RECRUITING

Sponsor

Finn, Olivera, PhD

Enrollment

Started

2024

Primary outcome

Immunogenicity (of MUC1 vaccine)

Ductal Carcinoma in Situ

Gene Expression Following Short Term Exposure to Neoadjuvant Endocrine Therapy in Invasive Breast Cancer

NCT00588003Phase 1COMPLETED

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

Started

2004

Primary outcome

To determine whether short term exposure to endocrine therapy (anastrozole) induces changes in gene expression in human invasive breast cancer.

Breast Cancer

Impact of Estradiol Addback

NCT01862835Phase 1COMPLETED

Sponsor

Mayo Clinic

Enrollment

Started

2013

Primary outcome

BioStatistical Analysis

Normal Healthy Volunteers

Open-label Phase 1b Study of ARQ 092 in Combination With Anastrozole

NCT02476955Phase 1TERMINATED

Sponsor

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Enrollment

Started

2015

Primary outcome

Number of treatment emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Solid TumorsOvarian CancerEndometrial Cancer

Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fed Conditions

NCT01155960Phase 1COMPLETED

Sponsor

Dr. Reddy's Laboratories Limited

Enrollment

Started

2008

Primary outcome

Bioavailability based on Cmax and AUC parameters

Healthy

Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fasting Conditions

NCT01155947Phase 1COMPLETED

Sponsor

Dr. Reddy's Laboratories Limited

Enrollment

Started

2008

Primary outcome

Bioavailability based on Cmax and AUC parameters

Healthy

MK2206 in Combination With Anastrozole, Fulvestrant, or Anastrozole and Fulvestrant in Treating Postmenopausal Women With Metastatic Breast Cancer

NCT01344031Phase 1COMPLETED

Sponsor

National Cancer Institute (NCI)

Enrollment

Started

2011

Primary outcome

MTD of Akt inhibitor MK-2206 in combination with anastrozole determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) (Phase IA)

Estrogen Receptor PositiveInvasive Breast CarcinomaRecurrent Breast CarcinomaStage IV Breast Cancer AJCC v6 and v7

Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition

NCT04438733Phase 1UNKNOWN

Sponsor

The Affiliated Hospital of Qingdao University

Enrollment

Started

2020

Primary outcome

the ratios of geometrical mean

Healthy Volunteers

Anastrozole 1 mg Tablets Under Fasting Conditions

NCT01182181Phase 1COMPLETED

Sponsor

Teva Pharmaceuticals USA

Enrollment

Started

2005

Primary outcome

Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)

Healthy

A Trial to Evaluate Sacituzumab Govitecan in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Metastatic Breast Cancer Progressed on CDK4/6 Inhibitors

NCT07163481Phase 1NOT_YET_RECRUITING

Sponsor

Hunan Cancer Hospital

Enrollment

Started

2025

Primary outcome

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Stage IV (Metastatic) Breast Cancer

A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole

NCT03314298Phase 1COMPLETED

Sponsor

Havah Therapeutics Pty Ltd

Enrollment

Started

2017

Primary outcome

testosterone Cmax

Mammographic Density

Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.

NCT04757532Phase 1COMPLETED

Sponsor

Parc de Salut Mar

Enrollment

Started

2020

Primary outcome

Urine concentration of bupropion metabolites

Healthy Volunteers

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This page is for informational and research purposes only. All information is based on published scientific literature and does not constitute medical advice, diagnosis, or treatment recommendations. Many substances listed may not be approved for human use and may be subject to drug regulation laws (e.g., AMG in Germany, FDA in the US). PepStack does not encourage the use of any substance on humans. Always consult a qualified healthcare professional before making any health-related decisions. Use of this information is entirely at your own risk. PepStack assumes no liability for the accuracy, completeness, or timeliness of the content provided. Full disclaimer