Hormone · Profile

Exemestane

Aromasin · Steroidal AI

Hormone ManagementApproved

MW: 296.4g/mol
Formula: C20H24O2

Exemestane is a steroidal aromatase inhibitor primarily produced in the adrenal glands, which plays a crucial role in the biosynthesis of estrogens. Researchers primarily study exemestane for its effectiveness in managing estrogen receptor-positive breast cancer, particularly in postmenopausal women. Key findings from recent studies indicate that exemestane, when combined with the mTOR inhibitor everolimus, significantly improves progression-free survival compared to exemestane alone, suggesting enhanced therapeutic efficacy in patients with resistance to previous treatments. Additionally, clinical evidence indicates that the combination of exemestane with other agents, such as entinostat, may further extend progression-free survival in advanced breast cancer settings. Current research continues to explore the optimal use of exemestane in various treatment regimens, highlighting its relevance in the ongoing battle against hormone-responsive malignancies.

Overview

Übersicht

Exemestane is a synthetic steroidal compound classified as an aromatase inhibitor. It is primarily used in the management of hormone-sensitive breast cancer. Exemestane is chemically related to the natural substrate androstenedione and is produced synthetically for therapeutic use. As a member of the steroidal aromatase inhibitor class, it is distinct from non-steroidal inhibitors like letrozole and anastrozole. Researchers have focused on exemestane's role in reducing estrogen levels in postmenopausal women, which is crucial in treating estrogen receptor-positive breast cancer. It is also explored in combination therapies, such as with mTOR inhibitors like everolimus, to overcome resistance to endocrine therapies. Exemestane acts by irreversibly binding to and inhibiting the aromatase enzyme, which is responsible for converting androgens to estrogens in peripheral tissues. This inhibition leads to a significant reduction in circulating estrogen levels, thereby slowing the growth of estrogen-dependent tumors. Pharmacokinetically, exemestane has a half-life of approximately 24 hours, allowing for once-daily oral dosing. It is metabolized primarily in the liver via oxidation and reduction, and its bioavailability is enhanced when taken with food. Clinically, exemestane is approved for use in postmenopausal women with advanced breast cancer, particularly after disease progression following non-steroidal aromatase inhibitors. It is recognized by regulatory agencies worldwide, including the FDA, for its efficacy in this context.

Chemical profile

Chemische Struktur

Formel	C20H24O2
Molekulargewicht	296.4g/mol
CAS-Nummer	107868-30-4
PubChem CID	60198

Mechanism

Wirkmechanismus

Exemestane acts on the aromatase enzyme, leading to the irreversible inhibition of estrogen biosynthesis. This reduction in estrogen levels results in decreased stimulation of estrogen receptor-positive breast cancer cells, thereby inhibiting tumor growth.

Mechanism

Signalweg

Exemestane is a steroidal aromatase inhibitor that irreversibly binds to the aromatase enzyme, inhibiting the conversion of androgens to estrogens in peripheral tissues, thereby reducing estrogen levels. This action primarily affects estrogen receptor-positive (ER+) breast cancer cells, leading to decreased activation of estrogen receptor signaling pathways and subsequent inhibition of cell proliferation and tumor growth. The complete mechanism of action is not fully understood, particularly regarding the downstream effects on various signaling pathways involved in cancer resistance and progression.

Half-Life & Pharmacokinetics

POOral

Approximately 24 hours

Bioavailability is increased when taken with food.

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 tightly closed container.

Solubility

Löslichkeit

Exemestane is poorly soluble in water but soluble in ethanol and organic solvents.

Legal Status

🇩🇪DE

Verschreibungspflichtig (prescription only); not a controlled substance under BtMG.

🇺🇸US

FDA approved for prescription use; not a controlled substance.

🇦🇺AU

TGA 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 efficacy and safety of exemestane in combination with mTOR inhibitors, particularly in diverse populations and those with varying stages of breast cancer. Additionally, contradictory findings on the effectiveness of exemestane compared to other aromatase inhibitors, such as letrozole, in treating conditions like endometriosis highlight the need for larger randomized controlled trials to clarify these differences. Further research is needed to explore the specific mechanisms of resistance to exemestane and the role of biomarkers, such as protein lysine acetylation, in predicting treatment outcomes.

159 Research Publications

4,470

Total Citations

Human/RCT

3.3

Avg. Influence

2020

Latest

Sort

Filter

01Top

#01

Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.

Pagani Olivia, et al. · The New England journal of medicine · 2014

HumanInfluence31.0

712

Researchers observed that adjuvant treatment with exemestane plus ovarian suppression significantly improved disease-free survival compared to tamoxifen plus ovarian suppression in premenopausal women with hormone-receptor-positive early breast cancer.

Key findings

01Exemestane plus ovarian suppression significantly reduced the risk of cancer recurrence compared to tamoxifen plus ovarian suppression.
02The 5-year disease-free survival rate was 91.1% for the exemestane group.
03Overall survival rates were similar between the two treatment groups.

PubMed

02Top

#02

Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer.

Francis Prudence A, et al. · The New England journal of medicine · 2018

HumanInfluence34.0

580

Researchers observed that premenopausal women receiving exemestane plus ovarian suppression had significantly lower recurrence rates compared to those receiving tamoxifen plus ovarian suppression, indicating a benefit of the former treatment regimen.

Key findings

01Exemestane plus ovarian suppression resulted in lower recurrence rates than tamoxifen plus ovarian suppression.
02Tamoxifen plus ovarian suppression improved survival rates compared to tamoxifen alone.
03Higher rates of side effects were observed in groups receiving ovarian suppression.

PubMed

03Top

#03

Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial.

HumanInfluence17.0

373

The study demonstrated no significant difference in disease-free survival between exemestane monotherapy and sequential tamoxifen followed by exemestane in postmenopausal women with hormone-receptor-positive early breast cancer.

PubMed

#04

Oral bioavailability enhancement of exemestane from self-microemulsifying drug delivery system (SMEDDS).

AnimalInfluence4.0

161

Researchers observed that a self-microemulsifying drug delivery system significantly enhanced the oral bioavailability of exemestane in female Wistar rats.

PubMed

#05

Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials.

HumanInfluence9.0

137

The study demonstrated that adjuvant exemestane plus ovarian function suppression significantly improved disease-free survival and distant recurrence-free interval compared to tamoxifen plus ovarian function suppression in premenopausal women with breast cancer after 13 years of follow-up.

PubMed

#06

The BOLERO-2 trial: the addition of everolimus to exemestane in the treatment of postmenopausal hormone receptor-positive advanced breast cancer.

HumanInfluence3.0

123

The study demonstrated that the addition of everolimus to exemestane significantly improves progression-free survival in postmenopausal women with hormone receptor-positive advanced breast cancer.

PubMed

#07

ESR1 Mutations and Overall Survival on Fulvestrant versus Exemestane in Advanced Hormone Receptor-Positive Breast Cancer: A Combined Analysis of the Phase III SoFEA and EFECT Trials.

Turner Nicholas C, et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2020

HumanInfluence5.0

121

The study demonstrated that patients with ESR1 mutations had inferior progression-free and overall survival when treated with exemestane compared to fulvestrant in advanced hormone receptor-positive breast cancer.

Key findings

01Fulvestrant and exemestane were compared in patients who progressed on prior therapy.
02The study involved analyzing serum and plasma samples from hundreds of patients.
03The trials aimed to improve treatment options for metastatic breast cancer.

PubMed

#08

Aromatase inhibitors: are there differences between steroidal and nonsteroidal aromatase inhibitors and do they matter?

ReviewInfluence3.0

115

The study demonstrated that steroidal aromatase inhibitors like exemestane may have different interactions and clinical implications compared to nonsteroidal aromatase inhibitors in breast cancer treatment.

PubMed

#09

Exemestane (FCE 24304), a new steroidal aromatase inhibitor.

HumanInfluence1.0

Researchers observed that exemestane is a potent irreversible aromatase inhibitor with a favorable safety profile and significant estrogen suppression in postmenopausal women.

PubMed

#10

Endocrine and clinical endpoints of exemestane as neoadjuvant therapy.

ReviewInfluence1.0

Researchers observed that exemestane significantly reduced aromatization and tumor volume in postmenopausal women with estrogen receptor-rich tumors during neoadjuvant therapy.

PubMed

Clinical Trials (134)

Preclinical

Phase I

Phase II

Phase III

Approved

134

Total Trials

99,281

Total Enrolled

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole

NCT05635357COMPLETED

Sponsor

Brigham and Women's Hospital

Enrollment

16,989

Started

2022

Primary outcome

Time to dementia onset

Breast Cancer

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

NCT04852081UNKNOWN

Sponsor

Blokhin's Russian Cancer Research Center

Enrollment

1,000

Started

2021

Primary outcome

To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Moscow

Breast Cancer Stage IV

Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)

NCT01050634COMPLETED

Sponsor

Pfizer

Enrollment

980

Started

2005

Primary outcome

Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores

Post Menopausal Women With Early Breast Cancer

Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin

NCT00932165COMPLETED

Sponsor

Pfizer

Enrollment

451

Started

2004

Primary outcome

Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane

Breast Neoplasms

Treatment of Canadian Men and Pre/Peri/Post-menopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy

NCT02753686COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

440

Started

2016

Primary outcome

Duration on Treatment

HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer

A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients

NCT01305239TERMINATED

Sponsor

Pfizer

Enrollment

398

Started

2008

Primary outcome

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Breast Cancer

A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

NCT01121549TERMINATED

Sponsor

Pfizer

Enrollment

378

Started

2010

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity

Invasive Early Breast Cancer

Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer

NCT04389424UNKNOWN

Sponsor

Instituto Jalisciense de Cancerologia

Enrollment

300

Started

2017

Primary outcome

Hidroxy Vitamin D Concentration

Breast CancerEndocrine TherapyEndocrine Therapy Adverse ReactionVitamin D DeficiencyNutrition DisordersObesity

Analysis of Tumor Tissue and Circulating Genetic Material in the Blood to Obtain Further Insight in the Effectiveness of Everolimus When Combined With Exemestane

NCT02109913UNKNOWN

Sponsor

Amsterdam UMC, location VUmc

Enrollment

175

Started

2014

Primary outcome

Biomarker Evaluation from Primary Tumor Tissue, New Tumor Biopsies and Blood Samples

Hormone Receptor Positive Malignant Neoplasm of BreastMetastatic Breast Cancer

Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer

NCT00066586COMPLETED

Sponsor

NCIC Clinical Trials Group

Enrollment

Started

2001

Primary outcome

Change in breast density as measured by Boyd Scale at 1 year

Breast Cancer

Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients

NCT01814397COMPLETED

Sponsor

University of Michigan Rogel Cancer Center

Enrollment

Started

2009

Primary outcome

Mean Pain50 Assessed at Baseline, 3 Months and 6 Months

Breast CancerPainArthralgia

Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

NCT01239745TERMINATED

Sponsor

Pfizer

Enrollment

Started

2011

Primary outcome

Number of Participants With Adverse Events (AEs)

Breast Neoplasms

Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Hormone Therapy

NCT01720602COMPLETED

Sponsor

University of Washington

Enrollment

Started

2012

Primary outcome

Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST

Male Breast CancerRecurrent Breast CancerStage IV Breast Cancer

Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease

NCT00200174COMPLETED

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

Started

1999

Primary outcome

To evaluate the clinical safety and toxicity of raloxifene in combination with exemestane in postmenopausal women with a hx of AJCC Stage 0, I, II, or III breast cancer, who have no clinical evidence of disease, after completion of all planned adjuvant

Breast Cancer

Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Aromatase Inhibitor Therapy

NCT01153672COMPLETED

Sponsor

University of Washington

Enrollment

Started

2010

Primary outcome

Rate of Clinical Benefit According to RECIST

Male Breast CancerRecurrent Breast CancerStage IV Breast Cancer

Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer

NCT02023359COMPLETED

Sponsor

Novartis Healthcare A/S

Enrollment

Started

2013

Primary outcome

Adverse Events

Breast Cancer

A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer

NCT00649090Phase 4COMPLETED

Sponsor

Pfizer

Enrollment

1,549

Started

2005

Primary outcome

Assess for serious adverse events

Breast Neoplasms

Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China

NCT01176916Phase 4COMPLETED

Sponsor

Pfizer

Enrollment

564

Started

2011

Primary outcome

Time-to-Event

Breast Neoplasms

Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane

NCT00036270Phase 3COMPLETED

Sponsor

Pfizer

Enrollment

9,779

Started

2001

Primary outcome

Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years

Breast Neoplasms

Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer

NCT00279448Phase 3COMPLETED

Sponsor

Pfizer

Enrollment

9,779

Started

2002

Primary outcome

To compare recurrence free survival between two treatment groups.

Breast Neoplasms

Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer

NCT00066573Phase 3COMPLETED

Sponsor

NCIC Clinical Trials Group

Enrollment

7,576

Started

2003

Primary outcome

Event-free Survival

Breast Cancer

Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer

NCT00038467Phase 3COMPLETED

Sponsor

Pfizer

Enrollment

4,740

Started

1998

Primary outcome

Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study

Breast Neoplasms

Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer

NCT00003418Phase 3UNKNOWN

Sponsor

International Collaborative Cancer Group

Enrollment

4,400

Started

1998

Breast Cancer

Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer

NCT00032136Phase 3COMPLETED

Sponsor

Cancer Research Campaign Clinical Trials Centre

Enrollment

4,400

Started

2001

Primary outcome

Relapse-free survival

Breast Cancer

A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

NCT06492616Phase 3RECRUITING

Sponsor

Stemline Therapeutics, Inc.

Enrollment

4,220

Started

2024

Primary outcome

Invasive Breast Cancer-Free Survival (IBCFS)

Breast Cancer

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

NCT06223698Phase 3NOT_YET_RECRUITING

Sponsor

Region Örebro County

Enrollment

3,832

Started

2025

Primary outcome

Overall survival

Breast Cancer

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

NCT00066690Phase 3COMPLETED

Sponsor

ETOP IBCSG Partners Foundation

Enrollment

3,066

Started

2003

Primary outcome

Disease-free Survival

Estrogen Receptor Positive Breast CancerProgesterone Receptor Positive TumorRecurrent Breast CarcinomaStage IA Breast CancerStage IB Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage IIIA Breast Cancer

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

NCT00066703Phase 3COMPLETED

Sponsor

ETOP IBCSG Partners Foundation

Enrollment

2,672

Started

2003

Primary outcome

Disease-free Survival

Breast Cancer

Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

NCT07391774Phase 3RECRUITING

Sponsor

National Cancer Institute (NCI)

Enrollment

1,978

Started

2026

Primary outcome

Invasive breast cancer-free survival (iBCFS)

Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Estrogen Receptor-Positive Breast CarcinomaHER2-Negative Breast Carcinoma

De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

NCT04852887Phase 3RECRUITING

Sponsor

NRG Oncology

Enrollment

1,670

Started

2021

Primary outcome

Time to invasive or noninvasive IBTR.

Stage I Breast Cancer

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

NCT05827081Phase 3RECRUITING

Sponsor

Novartis Pharmaceuticals

Enrollment

1,400

Started

2024

Primary outcome

Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years

Early Breast Cancer

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

NCT04975308Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Eli Lilly and Company

Enrollment

874

Started

2021

Primary outcome

Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B)

Breast NeoplasmsNeoplasm Metastasis

Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)

NCT05891093Phase 3RECRUITING

Sponsor

Fudan University

Enrollment

766

Started

2023

Primary outcome

invasive disease free survival (iDFS)

Breast Cancer

Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer

NCT02404051Phase 3UNKNOWN

Sponsor

Consorzio Oncotech

Enrollment

745

Started

2015

Primary outcome

Progression-free survival (PFS1)

Metastatic Breast CancerBreast CancerHormone Receptor Positive TumorHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastLocally Advanced Malignant Neoplasm

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

NCT00863655Phase 3COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

724

Started

2009

Primary outcome

Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.

Breast Cancer

The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer

NCT00065325Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

694

Started

2003

Primary outcome

Time to disease progression (TTP)

Locally Advanced Breast CancerMetastatic Breast Cancer

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

NCT02028507Phase 3COMPLETED

Sponsor

Spanish Breast Cancer Research Group

Enrollment

693

Started

2014

Primary outcome

Progression-Free Survival (PFS)

Metastatic Breast Cancer

Study of Exemestane After Anastrozole or Letrozole Treatment of Postmenopausal Women With Hormone Responsive Breast Cancer

NCT00902954Phase 3UNKNOWN

Sponsor

Fudan University

Enrollment

540

Started

2008

Primary outcome

disease free survival

Breast Cancer

Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer

NCT07061717Phase 3NOT_YET_RECRUITING

Sponsor

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

Enrollment

474

Started

2025

Primary outcome

Progression-Free Survival (PFS) as Assessed by the Investigator

Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer

A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.

NCT07062965Phase 3RECRUITING

Sponsor

Pfizer

Enrollment

400

Started

2025

Primary outcome

Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Breast Cancer

Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive, Locally Advanced or Metastatic Breast Cancer

NCT03538171Phase 3UNKNOWN

Sponsor

Taizhou EOC Pharma Co., Ltd.

Enrollment

375

Started

2018

Primary outcome

PFS (The Randomized Double-blinded Part)

Advanced Breast Cancer

A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)

NCT05306340Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Genentech, Inc.

Enrollment

373

Started

2022

Primary outcome

Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population

Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer

Trial of Chidamide in Combination With Exemestane in Patients With Advanced Breast Cancer

NCT02482753Phase 3COMPLETED

Sponsor

Chipscreen Biosciences, Ltd.

Enrollment

365

Started

2015

Primary outcome

progression-free survival (PFS), double-blinded period

Breast Cancer

Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer

NCT00002777Phase 3COMPLETED

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

342

Started

1996

Breast Cancer

4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer

NCT01626222Phase 3COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

301

Started

2012

Primary outcome

Overall Response Rate (ORR) after 24 weeks of treatment

Metastatic Breast Cancer

A Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations （STEP）

NCT03137368Phase 3UNKNOWN

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

300

Started

2018

Primary outcome

Disease free survival (DFS)

CYP2D6 Polymorphism

Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

NCT00143390Phase 3COMPLETED

Sponsor

Pfizer

Enrollment

298

Started

2005

Primary outcome

Time to Progression (TTP) - Expert Evaluation Committee Assessment

Breast Neoplasms

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer

NCT07024173Phase 3RECRUITING

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

240

Started

2025

Primary outcome

Progression free survival (PFS) evaluated by the blinded independent central review (BICR).

Locally Advanced Breast CancerMetastatic Breast Cancer

Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

NCT03176238Phase 3COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

235

Started

2013

Primary outcome

Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades

Post Menopausal Breast Cancer

PreOperative Endocrine Therapy for Individualised Care With Abemaciclib

NCT04584853Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

123

Started

2020

Primary outcome

Time to tumour (local or distant disease) recurrence

Breast Cancer Female

Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients

NCT02995772Phase 3COMPLETED

Sponsor

Dharmais National Cancer Center Hospital

Enrollment

122

Started

2011

Primary outcome

Overall survival

Breast Cancer

1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer

NCT01303679Phase 3TERMINATED

Sponsor

ARCAGY/ GINECO GROUP

Enrollment

117

Started

2010

Primary outcome

Primary free survival

First Line Metastatic Breast Cancer

Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02

NCT00659373Phase 3COMPLETED

Sponsor

ETOP IBCSG Partners Foundation

Enrollment

Started

2007

Primary outcome

Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)

Breast CancerFatigueSleep Disorders

Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer

NCT01237327Phase 3COMPLETED

Sponsor

Pfizer

Enrollment

Started

2001

Primary outcome

Overall Survival

Metastatic Breast Cancer

Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer

NCT04869943Phase 3TERMINATED

Sponsor

Veru Inc.

Enrollment

Started

2021

Primary outcome

To demonstrate the efficacy of Enobosarm in the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).

Metastatic Breast Cancer

Premenopausal Endocrine Responsive Chemotherapy Trial

NCT00066807Phase 3TERMINATED

Sponsor

ETOP IBCSG Partners Foundation

Enrollment

Started

2003

Primary outcome

Disease-free Survival

Breast Cancer

Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)

NCT00944918Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

Started

2008

Primary outcome

Progression-free survival

Progression-free Survival

Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer

NCT05065411Phase 3TERMINATED

Sponsor

Veru Inc.

Enrollment

Started

2022

Primary outcome

Primary endpoint for the study is the median progression free survival (PFS) in the Enobosarm Combination Group compared to the Control Treatment Group in patients with AR% nuclei staining ≥40%. Progression will be defined based on RECIST 1.1 criteria

Metastatic Breast Cancer

Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer

NCT05253066Phase 2/3UNKNOWN

Sponsor

Shengjing Hospital

Enrollment

130

Started

2022

Primary outcome

ORR

Breast Neoplasms

Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients

NCT06009627Phase 2/3COMPLETED

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

119

Started

2023

Primary outcome

Objective response rate (ORR) for treatment

Breast Cancer

Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer

NCT00684216Phase 2/3TERMINATED

Sponsor

The Netherlands Cancer Institute

Enrollment

Started

2008

Primary outcome

Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30

Breast Cancer

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

NCT04059484Phase 2TERMINATED

Sponsor

Sanofi

Enrollment

367

Started

2019

Primary outcome

Progression Free Survival (PFS)

Breast Cancer Metastatic

A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment

NCT06105632Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Pfizer

Enrollment

333

Started

2024

Primary outcome

Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Advanced or Metastatic Breast Cancer

Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study

NCT07179939Phase 2NOT_YET_RECRUITING

Sponsor

Fudan University

Enrollment

288

Started

2025

Primary outcome

PFS

HER2-positive Breast Cancer

Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients

NCT03272477Phase 2COMPLETED

Sponsor

Palleos Healthcare GmbH

Enrollment

257

Started

2017

Primary outcome

Pathological complete response (pCR)

Breast Neoplasms

Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

NCT02007512Phase 2COMPLETED

Sponsor

Pfizer

Enrollment

247

Started

2013

Primary outcome

Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS)

Breast Cancer

Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer

NCT02676986Phase 2COMPLETED

Sponsor

Queen Mary University of London

Enrollment

221

Started

2015

Primary outcome

Determine the difference in geometric mean change in Ki67 expression between the two treatment groups of patients in the ER+ Cohort

Primary Breast Cancer ER+vePrimary Breast Cancer AR+ve TNBN

Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

NCT01698918Phase 2COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

202

Started

2013

Primary outcome

First-line Treatment: Progression-free Survival (PFS)

Hormone Receptor Positive Breast Cancer

Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients

NCT07101159Phase 2NOT_YET_RECRUITING

Sponsor

Fujian Cancer Hospital

Enrollment

200

Started

2025

Primary outcome

3-years Invasive Disease-Free Survival (iDFS)

Early Breast CancerAdjuvant TherapyHormone Receptor Positive / HER2-negative Breast Cancer

A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR+ MBC

NCT02592746Phase 2UNKNOWN

Sponsor

Samsung Medical Center

Enrollment

182

Started

2016

Primary outcome

Progression free survival (PFS) in patients with metastatic breast cancer who received palbociclib plus exemestane with goserelin versus capecitabine

Metastatic Breast Cancer

Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer

NCT02598557Phase 2COMPLETED

Sponsor

National Cancer Institute (NCI)

Enrollment

180

Started

2016

Primary outcome

Percent Change in Time of Circulating Estradiol SPE in Each Arm

Stage 0 Breast Cancer AJCC v6 and v7Stage I Breast Cancer AJCC v7Stage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage II Breast Cancer AJCC v6 and v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7

A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor

NCT03312738Phase 2COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

159

Started

2017

Primary outcome

Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessment

Advanced Breast Cancer

Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients

NCT02646735Phase 2UNKNOWN

Sponsor

Chinese Academy of Medical Sciences

Enrollment

148

Started

2015

Primary outcome

PFS

Breast Cancer

Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer

NCT07499999Phase 2NOT_YET_RECRUITING

Sponsor

Dana-Farber Cancer Institute

Enrollment

140

Started

2026

Primary outcome

Difference in Overall Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Between the Two Arms at 12 Months

Breast CancerDuctal CarcinomaEstrogen-receptor-positive Breast CancerAtypical Lobular HyperplasiaBRCA2 MutationCHEK2 Gene MutationAtaxia Telangiectasia Mutated Gene Mutation

Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

NCT03291886Phase 2COMPLETED

Sponsor

Kyowa Kirin Co., Ltd.

Enrollment

133

Started

2017

Primary outcome

Progression Free Survival(PFS) defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1)

Advanced or Recurrent Breast Cancer

Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer

NCT00676663Phase 2COMPLETED

Sponsor

Syndax Pharmaceuticals

Enrollment

130

Started

2008

Primary outcome

Progression-free Survival (PFS)

Breast CancerEstrogen Receptor-Positive Breast CancerBreast Cancer, Estrogen Receptor-PositiveER+ Breast Cancer

Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)

NCT06428396Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Merck Sharp & Dohme LLC

Enrollment

120

Started

2024

Primary outcome

Progression-free Survival (PFS)

Metastatic Breast Cancer

Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer

NCT02049957Phase 2COMPLETED

Sponsor

Calithera Biosciences, Inc

Enrollment

118

Started

2014

Primary outcome

Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Breast Cancer

A Study of Ridaforolimus (MK-8669) in Combination With Dalotuzumab (MK-0646) Compared to Standard of Care Treatment in Estrogen Receptor Positive Breast Cancer Patients (MK-8669-041 AM3)

NCT01234857Phase 2COMPLETED

Sponsor

Merck Sharp & Dohme LLC

Enrollment

115

Started

2010

Primary outcome

Progression free survival (PFS)

Breast Cancer

To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy

NCT02549430Phase 2COMPLETED

Sponsor

Fondazione Sandro Pitigliani

Enrollment

115

Started

2012

Primary outcome

Incidence of complete response (CR), partial response (PR) or stable disease (SD) ≥24 weeks (clinical benefit)

Breast Cancer

Exemestane With or Without ATN-224 in Treating Postmenopausal Women With Recurrent or Advanced Breast Cancer

NCT00674557Phase 2TERMINATED

Sponsor

Cancer Research UK

Enrollment

111

Started

2008

Primary outcome

Progression-free survival

Breast Cancer

Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen

NCT00038103Phase 2COMPLETED

Sponsor

Pfizer

Enrollment

111

Started

2002

Primary outcome

Number of Subjects With Clinical Benefit

Breast Neoplasms

Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women

NCT00040014Phase 2TERMINATED

Sponsor

Pfizer

Enrollment

100

Started

2002

Primary outcome

To determine the pharmacodynamic equivalence at steady state of the IM formulation of exemestane with the oral formulation in terms of plasma estrone sulphate inhibitory effect in postmenopausal women with advanced breast cancer.

Breast Neoplasms

Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer

NCT02069093Phase 2COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

Started

2014

Primary outcome

Number of Participants With Stomatitis Grade ≥ 2

Advanced Breast Cancer

An Exploratory Study of Pertuzumab and Trastuzumab in Combination With Palbociclib and Exemestane as Neoadjuvant Therapy for Triple-Positive Breast Cancer

NCT07299890Phase 2NOT_YET_RECRUITING

Sponsor

Anhui Provincial Cancer Hospital

Enrollment

Started

2025

Primary outcome

tpCR rate，total physiological complex response

Breast Cancer

Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy

NCT05472792Phase 2RECRUITING

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

Started

2022

Primary outcome

Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30

Breast CancerQuality of Life

A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064)

NCT01605396Phase 2COMPLETED

Sponsor

Merck Sharp & Dohme LLC

Enrollment

Started

2012

Primary outcome

1. Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)

Breast Neoplasms

Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients

NCT04300790Phase 2COMPLETED

Sponsor

MedSIR

Enrollment

Started

2020

Primary outcome

Assess the rate of patients with G3-4 hyperglycemia (HG) by CTCAE v4.03 over the first 2 cycles of treatment with alpelisib (BYL719) (Cohorts A and B)

Breast Cancer

Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer

NCT04858516Phase 2UNKNOWN

Sponsor

Guangdong Provincial People's Hospital

Enrollment

Started

2021

Primary outcome

pathological complete response(ypT0/is,ypN0, pCR)

Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer

Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer

NCT03555877Phase 2COMPLETED

Sponsor

GBG Forschungs GmbH

Enrollment

Started

2018

Primary outcome

Locally-assessed progression-free survival (PFS)

Breast Cancer Metastatic

Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women

NCT02028364Phase 2COMPLETED

Sponsor

Jules Bordet Institute

Enrollment

Started

2014

Primary outcome

PFS based on RECIST criteria 1.1.

Breast Cancer

Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

NCT02476786Phase 2RECRUITING

Sponsor

Washington University School of Medicine

Enrollment

Started

2017

Primary outcome

Response rate

Breast CancerCancer of BreastBreast NeoplasmsCancer of the Breast

Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer

NCT00073073Phase 2COMPLETED

Sponsor

Georgetown University

Enrollment

Started

2003

Primary outcome

Percent Change in Mammographic Density at 1 Year on Exemestane

Breast Neoplasms

Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients

NCT00174343Phase 2COMPLETED

Sponsor

Pfizer

Enrollment

Started

2001

Primary outcome

To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)

Breast Neoplasms

Neoadjuvant Chemo-endocrine Therapy and Immunotherapy for Pre-menopausal Luminal B Breast Cancer Patients

NCT04659551Phase 2COMPLETED

Sponsor

Istituto Oncologico Veneto IRCCS

Enrollment

Started

2017

Primary outcome

pathological complete response (pCR)

Breast Cancer

Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer

NCT03300557Phase 2COMPLETED

Sponsor

National Cancer Institute (NCI)

Enrollment

Started

2017

Primary outcome

Change in Tumor Proliferation

Atypical HyperplasiaEndometrial Atypical Hyperplasia/Endometrioid Intraepithelial NeoplasiaEndometrial CarcinomaFIGO Grade 1 Endometrial Endometrioid AdenocarcinomaFIGO Grade 2 Endometrial Endometrioid Adenocarcinoma

Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

NCT00201864Phase 2COMPLETED

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

Started

2005

Primary outcome

Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.

Breast Cancer

Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis

NCT03691493Phase 2COMPLETED

Sponsor

Emory University

Enrollment

Started

2019

Primary outcome

Response Rate

Anatomic Stage IV Breast Cancer AJCC v8Estrogen Receptor PositiveHER2/Neu NegativeMetastatic Breast CarcinomaMetastatic Malignant Neoplasm in the BoneProgesterone Receptor PositivePrognostic Stage IV Breast Cancer AJCC v8

Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors

NCT01831076Phase 2COMPLETED

Sponsor

University of Colorado, Denver

Enrollment

Started

2002

Primary outcome

Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings

Breast CancerStage II Breast CancerStage III Breast Cancer

Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer

NCT00810797Phase 2COMPLETED

Sponsor

City of Hope Medical Center

Enrollment

Started

2008

Primary outcome

Progression-free Survival

Breast Cancer

Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers

NCT00941330Phase 2COMPLETED

Sponsor

Emory University

Enrollment

Started

2009

Primary outcome

Pathologic Complete Response

Breast Cancer

Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

NCT04465097Phase 2COMPLETED

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Enrollment

Started

2020

Primary outcome

objective response rate (ORR) evaluated by MRI

Breast Cancer

Aromasin (Exemestane) in Patients With Recurrent or Refractory Stage II - IV Epithelial Ovarian Cancer

NCT00261027Phase 2COMPLETED

Sponsor

Ottawa Hospital Research Institute

Enrollment

Started

2003

Primary outcome

response rate toxicities

Ovarian Cancer

Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

NCT00194792Phase 2TERMINATED

Sponsor

University of Washington

Enrollment

Started

2005

Primary outcome

Number of Participants With Clinical Response

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

Exemestane-RAD001-Metformin

NCT01627067Phase 2TERMINATED

Sponsor

M.D. Anderson Cancer Center

Enrollment

Started

2012

Primary outcome

Progression-Free Survival (PFS)

Breast Cancer

Exemestane and Cyclophosphamide for Metastatic Breast Cancer

NCT01963481Phase 2COMPLETED

Sponsor

NYU Langone Health

Enrollment

Started

2013

Primary outcome

Progression-free Survival (PFS) Rate at 3 Months

Metastatic Beast Cancer

ER Reactivation Therapy for Breast Cancer

NCT02188745Phase 2COMPLETED

Sponsor

Dartmouth-Hitchcock Medical Center

Enrollment

Started

2016

Primary outcome

Clinical Benefit

Metastatic Breast Cancer

Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

NCT03874325Phase 2TERMINATED

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

Started

2019

Primary outcome

Rate of Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0

Breast CancerHormone Receptor Positive Tumor

Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

NCT06169124Phase 2ACTIVE_NOT_RECRUITING

Sponsor

National Cancer Institute (NCI)

Enrollment

Started

2024

Primary outcome

Objective response rate

Adult Ovarian Granulosa Cell Tumor

Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant

NCT00919399Phase 2COMPLETED

Sponsor

Institut Claudius Regaud

Enrollment

Started

2002

Primary outcome

Evaluate the objective response rate (complete response and partial response)

Breast Neoplasms

Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

NCT05150652Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Irada Ibrahim-zada

Enrollment

Started

2022

Primary outcome

Change in margin status

Breast CancerHER2-negative Breast CancerNode-negative Breast CancerBreast Carcinoma

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

NCT06630325Phase 2TERMINATED

Sponsor

OHSU Knight Cancer Institute

Enrollment

Started

2025

Primary outcome

Proportion of Participants Who Receive an ACT Therapy Based on a SMMART-ACT Tumor Board Recommendation.

Advanced Breast CarcinomaAdvanced Malignant Solid NeoplasmAdvanced Ovarian CarcinomaAdvanced Pancreatic CarcinomaAdvanced Prostate CarcinomaAdvanced SarcomaAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Stage IV Prostate Cancer AJCC v8

Exemestane in Post-Menopausal Women With NSCLC

NCT02666105Phase 2COMPLETED

Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

Started

2018

Primary outcome

Disease Response (RECIST)

Non-Small Cell Lung Cancer

Sorafenib and Letrozole, Anastrozole, or Exemestane in Treating Postmenopausal Women With Estrogen Receptor-Positive and/or Progesterone Receptor-Positive Metastatic Breast Cancer

NCT00573755Phase 2TERMINATED

Sponsor

Mayo Clinic

Enrollment

Started

2007

Primary outcome

Progression-free Survival

Breast Cancer

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

NCT01202591Phase 1/2COMPLETED

Sponsor

AstraZeneca

Enrollment

127

Started

2010

Primary outcome

Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)

FGFR Inhibition, Pharmacokinetics, BiomarkersER+ Breast Cancer

Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

NCT02732119Phase 1/2COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

104

Started

2016

Primary outcome

Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I

Breast Cancer

Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer

NCT05573126Phase 1/2RECRUITING

Sponsor

Ellipses Pharma

Enrollment

Started

2023

Primary outcome

Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment

Hormone Receptor-positive Breast CancerHormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast Cancer

Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer

NCT00905021Phase 1/2TERMINATED

Sponsor

Baylor Breast Care Center

Enrollment

Started

2010

Primary outcome

Time to Disease Progression in Weeks

Metastatic Breast Cancer

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

NCT05307705Phase 1RECRUITING

Sponsor

Eli Lilly and Company

Enrollment

260

Started

2022

Primary outcome

Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs)

Breast Cancer

BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer

NCT02123823Phase 1COMPLETED

Sponsor

Boehringer Ingelheim

Enrollment

164

Started

2014

Primary outcome

Progression-free Survival (PFS) - Phase II Part

Neoplasms

Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

NCT01857193Phase 1COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

132

Started

2013

Primary outcome

Dose Escalation: Incidence of Dose Limiting Toxicity (DLT)

Breast Cancer

Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

NCT01597193Phase 1COMPLETED

Sponsor

Pfizer

Enrollment

101

Started

2012

Primary outcome

Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)

Breast Cancer

BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors

NCT01938846Phase 1COMPLETED

Sponsor

Boehringer Ingelheim

Enrollment

Started

2013

Primary outcome

The Number of Patients With Dose-Limiting Toxicities (DLTs) in the First Course of Each Treatment Arm

Neoplasms

Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors

NCT02077933Phase 1COMPLETED

Sponsor

Novartis Pharmaceuticals

Enrollment

Started

2014

Primary outcome

Dose escalation : Incidence of dose Limiting Toxicity (DLTs)

NeoplasmsBreast NeoplasmsKidney NeoplasmsPancreatic Neuroendocine Neoplasms (pNETs)

Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

NCT02820961Phase 1COMPLETED

Sponsor

Syndax Pharmaceuticals

Enrollment

Started

2016

Primary outcome

Cmax, maximum plasma concentration

Breast CancerEstrogen Receptor Positive Breast Cancer

Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer

NCT03308201Phase 1COMPLETED

Sponsor

Tianjin Hemay Pharmaceutical Co., Ltd

Enrollment

Started

2017

Primary outcome

Number of participants with adverse events

Breast Cancer

A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer

NCT04572295Phase 1COMPLETED

Sponsor

Eisai Co., Ltd.

Enrollment

Started

2020

Primary outcome

Part 1: Recommended Dose (RD) of E7090 in Combination With Other Anticancer Agents

Breast Neoplasms

E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study

NCT07706374Phase 1NOT_YET_RECRUITING

Sponsor

University of North Carolina, Chapel Hill

Enrollment

Started

2026

Primary outcome

Number of participants with study-defined positive progesterone levels on Day 21

Poly Cystic Ovary Syndrome

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer

NCT02392611Phase 1COMPLETED

Sponsor

Gilead Sciences

Enrollment

Started

2015

Primary outcome

Number of Participants Experiencing Dose Limiting Toxicities (DLTs)

Solid Tumors and Lymphomas

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

NCT03554044Phase 1COMPLETED

Sponsor

University of California, San Francisco

Enrollment

Started

2020

Primary outcome

Number of patients with treatment-related toxicities by maximum observed grade

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Estrogen Receptor PositiveHER2/Neu NegativeInvasive Breast CarcinomaPrognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8Recurrent Breast Carcinoma

Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer

NCT02833155Phase 1COMPLETED

Sponsor

Taizhou EOC Pharma Co., Ltd.

Enrollment

Started

2016

Primary outcome

Adverse events, 12-lead ECG, blood pressure/pulse, temperature, laboratory parameters and physical examination.

Breast Cancer

Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

NCT02623751Phase 1COMPLETED

Sponsor

Kyowa Kirin Co., Ltd.

Enrollment

Started

2015

Primary outcome

Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events

Breast Cancer

Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer

NCT01594398Phase 1COMPLETED

Sponsor

Syndax Pharmaceuticals

Enrollment

Started

2012

Primary outcome

Difference in pharmacokinetics of entinostat when subjects fed or fasted

Lung CancerNon Small Cell Lung Cancer (NSCLC)Breast CancerEstrogen Receptor Breast Cancer

Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer

NCT01664754Phase 1COMPLETED

Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

Started

2012

Primary outcome

Tabulation, grading, and attribution of serious adverse events (SAEs) and adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

Stage IV Non-small Cell Lung Cancer

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