Clinical Trials

Exemestane is supported by a robust clinical research portfolio, with 276 trials recorded in the database. The compound is predominantly evaluated across various phases of study, spanning from Phase 1 safety evaluations to Phase 4 post-marketing trials. Primary clinical investigations focus on breast neoplasms, including advanced, recurrent, and metastatic breast cancer, while additional exploratory studies encompass conditions such as type 2 diabetes and mild cognitive impairment. Research initiatives are actively driven by diverse sponsors, ranging from global pharmaceutical companies to medical centers and government research offices. Across these studies, recruitment statuses vary from active recruitment and invitation-based enrollment to completed and active non-recruiting trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07190443 RECRUITING
Breast Cancer; Locoregional Recurrence; Abemaciclib; Endocrine Therapy
Japanese Foundation for Cancer Research
2025-02-07 PHASE3
NCT05512364 RECRUITING
ER-positive Breast Cancer; HER2-negative Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTC
2023-12-15 PHASE3
NCT06223698 NOT_YET_RECRUITING
Breast Cancer
Region Örebro County
2025-05-02 PHASE3
NCT07729046 NOT_YET_RECRUITING
Metastatic Invasive Breast Cancer; Resistant Breast Cancer; ER+, HER2-, Metastatic Breast Cancer
University of California, San Diego
2027-07 PHASE2
NCT07581834 RECRUITING
Breast Diseases; Breast Neoplasms; Dalpiciclib; Endocrine Breast Diseases; CDK4/6 Inhibitor; HR+/HER2- Breast Cancer
Fujian Cancer Hospital
2026-01-21 PHASE2
NCT07101159 NOT_YET_RECRUITING
Early Breast Cancer; Adjuvant Therapy; Hormone Receptor Positive / HER2-negative Breast Cancer
Fujian Cancer Hospital
2025-09 PHASE2
NCT04852887 RECRUITING
Stage I Breast Cancer
NRG Oncology
2021-06-23 PHASE3
NCT07179939 NOT_YET_RECRUITING
HER2-positive Breast Cancer
Fudan University
2025-09-10 PHASE2
NCT07349069 RECRUITING
Breast Cancer
Shandong Suncadia Medicine Co., Ltd.
2026-03-04 PHASE3
NCT06671912 SUSPENDED
Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage 1 Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Estrogen Receptor-Positive Breast Carcinoma; HER2-Negative Breast Carcinoma; Breast Ductal Carcinoma In Situ; Breast Lobular Carcinoma In Situ
Alliance for Clinical Trials in Oncology
2025-02-19 PHASE3
NCT04584853 ACTIVE_NOT_RECRUITING
Breast Cancer Female
Institute of Cancer Research, United Kingdom
2020-12-23 PHASE3
NCT05768139 RECRUITING
Breast Cancer; Solid Tumors, Adult
Eli Lilly and Company
2023-04-17 PHASE1; PHASE2
NCT04134598 ACTIVE_NOT_RECRUITING
Breast Cancer
Azienda Ospedaliero-Universitaria Careggi
2021-02-08 PHASE3
NCT05952557 ACTIVE_NOT_RECRUITING
Breast Cancer, Early Breast Cancer
AstraZeneca
2023-10-05 PHASE3
NCT05645536 ENROLLING_BY_INVITATION
Breast Cancer
Tolmar Inc.
2022-12-28 PHASE3
NCT06380751 RECRUITING
Advanced Breast Cancer
AstraZeneca
2024-08-01 PHASE3
NCT05827081 RECRUITING
Early Breast Cancer
Novartis Pharmaceuticals
2024-02-28 PHASE3
NCT06492616 RECRUITING
Breast Cancer
Stemline Therapeutics, Inc.
2024-09-27 PHASE3
NCT07391774 RECRUITING
Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Estrogen Receptor-Positive Breast Carcinoma; HER2-Negative Breast Carcinoma
National Cancer Institute (NCI)
2026-08-10 PHASE3
NCT07061717 NOT_YET_RECRUITING
Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2025-07-01 PHASE3
NCT06507618 RECRUITING
Breast Cancer Female
University of Virginia
2024-07-19 PHASE3
NCT07019363 RECRUITING
Breast Cancer; Adjuvant Therapy
Fudan University
2025-06-15 PHASE3
NCT07174336 RECRUITING
Breast Neoplasms; Neoplasm Metastasis
Eli Lilly and Company
2025-12-22 PHASE3
NCT07395336 RECRUITING
Breast Cancer
European Institute of Oncology
2026-05-11 PHASE2
NCT07706374 RECRUITING
Poly Cystic Ovary Syndrome
University of North Carolina, Chapel Hill
2026-08 PHASE1
NCT06075953 RECRUITING
Ductal Carcinoma in Situ
QuantumLeap Healthcare Collaborative
2024-02-17 PHASE2
NCT06680921 ACTIVE_NOT_RECRUITING
Locally Advanced or Metastatic Breast Cancer
Jiangsu Simcere Pharmaceutical Co., Ltd.
2024-11-14 PHASE3
NCT05467891 RECRUITING
Locoregional Recurrence; Hormone Receptor-positive Breast Cancer; HER2-negative Breast Cancer
Oana Danciu
2022-09-13 PHASE2
NCT02918084 ACTIVE_NOT_RECRUITING
Breast Cancer
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
2013-06 PHASE3
NCT05891093 RECRUITING
Breast Cancer
Fudan University
2023-06-01 PHASE3
NCT05573126 RECRUITING
Hormone Receptor-positive Breast Cancer; Hormone Receptor Positive HER-2 Negative Breast Cancer; Metastatic Breast Cancer
Ellipses Pharma
2023-01-11 PHASE1; PHASE2
NCT06979596 RECRUITING
Malignant Neoplasm
Merck Sharp & Dohme LLC
2025-08-11 PHASE2
NCT07299890 NOT_YET_RECRUITING
Breast Cancer
Anhui Provincial Cancer Hospital
2025-12-20 PHASE2
NCT05514054 ACTIVE_NOT_RECRUITING
Breast Neoplasms
Eli Lilly and Company
2022-10-04 PHASE3
NCT04985266 RECRUITING
ER+ Breast Cancer; HER2-negative Breast Cancer
Royal Marsden NHS Foundation Trust
2022-03-30 PHASE2
NCT07499999 NOT_YET_RECRUITING
Breast Cancer; Ductal Carcinoma; Estrogen-receptor-positive Breast Cancer; Atypical Lobular Hyperplasia; BRCA2 Mutation; CHEK2 Gene Mutation; Ataxia Telangiectasia Mutated Gene Mutation
Dana-Farber Cancer Institute
2026-09-09 PHASE2
NCT07062965 RECRUITING
Breast Cancer
Pfizer
2025-08-05 PHASE3
NCT06428396 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
Merck Sharp & Dohme LLC
2024-11-27 PHASE2
NCT05774951 RECRUITING
Breast Cancer, Early Breast Cancer
AstraZeneca
2023-03-31 PHASE3
NCT05472792 RECRUITING
Breast Cancer; Quality of Life
UNC Lineberger Comprehensive Cancer Center
2022-05-17 PHASE2
NCT06179303 RECRUITING
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Unresectable HER2-Negative Breast Carcinoma; Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma; Metastatic HER2-Negative Breast Carcinoma; Metastatic Hormone Receptor-Positive Breast Carcinoma
University of Washington
2024-07-22 PHASE2
NCT02476786 RECRUITING
Breast Cancer; Cancer of Breast; Breast Neoplasms; Cancer of the Breast
Washington University School of Medicine
2017-01-17 PHASE2
NCT06364267 RECRUITING
Breast Cancer
Andrea DeCensi
2025-10-01 PHASE2
NCT07024173 RECRUITING
Locally Advanced Breast Cancer; Metastatic Breast Cancer
Shandong Suncadia Medicine Co., Ltd.
2025-07-23 PHASE3
NCT05307705 RECRUITING
Breast Cancer
Eli Lilly and Company
2022-05-11 PHASE1
NCT07163481 NOT_YET_RECRUITING
Stage IV (Metastatic) Breast Cancer
Hunan Cancer Hospital
2025-10 PHASE1
NCT06016738 ACTIVE_NOT_RECRUITING
Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; ER Positive Breast Cancer; HER2 Negative Breast Carcinoma
Olema Pharmaceuticals, Inc.
2023-11-16 PHASE3
NCT04572295 COMPLETED
Breast Neoplasms
Eisai Co., Ltd.
2020-10-09 PHASE1
NCT07369505 RECRUITING
Breast Cancer Metastatic; Renal Cell Carcinoma (RCC); Neuroendocrine Tumors; Tuberous Sclerosis Complex (TSC); Hepatocellular Carcinoma (HCC)
SAPU NANO (US) LLC
2025-12-15 PHASE1
NCT04906395 ACTIVE_NOT_RECRUITING
Breast Cancer
Tolmar Inc.
2021-07-01 PHASE3
NCT06630325 TERMINATED
Advanced Breast Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Ovarian Carcinoma; Advanced Pancreatic Carcinoma; Advanced Prostate Carcinoma; Advanced Sarcoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8
OHSU Knight Cancer Institute
2025-06-24 PHASE2
NCT06169124 ACTIVE_NOT_RECRUITING
Adult Ovarian Granulosa Cell Tumor
National Cancer Institute (NCI)
2024-02-08 PHASE2
NCT06105632 ACTIVE_NOT_RECRUITING
Advanced or Metastatic Breast Cancer
Pfizer
2024-01-09 PHASE2
NCT05150652 COMPLETED
Breast Cancer; HER2-negative Breast Cancer; Node-negative Breast Cancer; Breast Carcinoma
Irada Ibrahim-zada
2022-02-18 PHASE2
NCT06235931 RECRUITING
Breast Neoplasms
Second Affiliated Hospital of Soochow University
2024-02-01
NCT05306340 ACTIVE_NOT_RECRUITING
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
Genentech, Inc.
2022-08-03 PHASE3
NCT06957379 ACTIVE_NOT_RECRUITING
HR+/HER2- Advanced/Metastatic Breast Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2024-02-29 PHASE2
NCT06009627 COMPLETED
Breast Cancer
Tianjin Medical University Cancer Institute and Hospital
2023-04-11 PHASE2; PHASE3
NCT02344472 UNKNOWN
Metastatic Breast Cancer
Prof. Wolfgang Janni
2015-09 PHASE3
NCT05463601 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2022-08-01 PHASE2
NCT06001762 ACTIVE_NOT_RECRUITING
Breast Cancer; Early-stage Breast Cancer; High Risk Breast Carcinoma
Dana-Farber Cancer Institute
2023-10-05 PHASE2
NCT04997798 UNKNOWN
Breast Cancer; Estrogen Receptor Positive Tumor; HER2-positive Breast Cancer
First Affiliated Hospital of Zhejiang University
2022-09-01 PHASE2
NCT02947685 ACTIVE_NOT_RECRUITING
HER-2 Positive Breast Cancer; Estrogen Receptor Positive Breast Cancer
Alliance Foundation Trials, LLC.
2017-06-21 PHASE3
NCT03280563 COMPLETED
Breast Neoplasms
Hoffmann-La Roche
2017-12-22 PHASE1; PHASE2
NCT03355157 COMPLETED
Metastatic Breast Cancer
GBG Forschungs GmbH
2018-03-01 PHASE4
NCT03179904 COMPLETED
Advanced Breast Carcinoma; HER2-Positive Breast Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; HER2-positive Breast Cancer
Mayo Clinic
2017-08-03 PHASE2
NCT04975308 ACTIVE_NOT_RECRUITING
Breast Neoplasms; Neoplasm Metastasis
Eli Lilly and Company
2021-10-04 PHASE3
NCT04272801 ACTIVE_NOT_RECRUITING
Breast Cancer Female
Shayna Showalter, MD
2020-04-07 PHASE2
NCT04858516 UNKNOWN
Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer
Guangdong Provincial People's Hospital
2021-04-30 PHASE2
NCT05079360 WITHDRAWN
Metastatic Breast Cancer
Veru Inc.
2023-03-15 PHASE2
NCT06288412 Recruiting
Diabetes Mellitus Type 2
Novo Nordisk A/S
2024-02-26 Phase 1
NCT04869943 TERMINATED
Metastatic Breast Cancer
Veru Inc.
2021-10-12 PHASE3
NCT02188745 COMPLETED
Metastatic Breast Cancer
Dartmouth-Hitchcock Medical Center
2016-03-11 PHASE2
NCT03554044 COMPLETED
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Estrogen Receptor Positive; HER2/Neu Negative; Invasive Breast Carcinoma; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Recurrent Breast Carcinoma
University of California, San Francisco
2020-02-05 PHASE1
NCT03300557 COMPLETED
Atypical Hyperplasia; Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia; Endometrial Carcinoma; FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma; FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
National Cancer Institute (NCI)
2017-11-15 PHASE2
NCT03137368 UNKNOWN
CYP2D6 Polymorphism
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
2018-08-09 PHASE3
NCT05065411 TERMINATED
Metastatic Breast Cancer
Veru Inc.
2022-04-11 PHASE3
NCT04465097 COMPLETED
Breast Cancer
First Affiliated Hospital, Sun Yat-Sen University
2020-07-08 PHASE2
NCT04460807 TERMINATED
Ovarian Cancer
Ente Ospedaliero Ospedali Galliera
2020-02-13 PHASE3
NCT03238703 WITHDRAWN
HER2/Neu Negative; Invasive Breast Carcinoma; Postmenopausal; Stage 0 Breast Cancer; Stage IA Breast Cancer
Fred Hutchinson Cancer Center
2018-09-01 PHASE4
NCT02894398 COMPLETED
Breast Cancer; Hormone Receptor Positive Tumor; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
iOMEDICO AG
2016-09-06 PHASE2
NCT01272037 ACTIVE_NOT_RECRUITING
Breast Ductal Carcinoma In Situ; Invasive Breast Carcinoma; Multicentric Breast Carcinoma; Multifocal Breast Carcinoma; Synchronous Bilateral Breast Carcinoma
National Cancer Institute (NCI)
2011-02-28 PHASE3
NCT01674140 ACTIVE_NOT_RECRUITING
Breast Cancer
SWOG Cancer Research Network
2013-09-12 PHASE3
NCT00253422 COMPLETED
Breast Cancer
Institute of Cancer Research, United Kingdom
2004-03-26 PHASE3
NCT04129216 COMPLETED
Breast Cancer
Johns Hopkins University
2019-02-20 PHASE2
NCT03691493 COMPLETED
Anatomic Stage IV Breast Cancer AJCC v8; Estrogen Receptor Positive; HER2/Neu Negative; Metastatic Breast Carcinoma; Metastatic Malignant Neoplasm in the Bone; Progesterone Receptor Positive; Prognostic Stage IV Breast Cancer AJCC v8
Emory University
2019-02-08 PHASE2
NCT06379282 Recruiting
Chronic Lymphocytic Leukemia|Frailty|Muscle Function|Immune Function|Lipid Cell; Tumor
University of Surrey|American Society of Hematology
2022-10-14 Not Applicable
NCT02990845 TERMINATED
Premenopausal Breast Cancer
National Taiwan University Hospital
2017-09-15 PHASE1; PHASE2
NCT05253066 UNKNOWN
Breast Neoplasms
Shengjing Hospital
2022-02-25 PHASE2; PHASE3
NCT03555877 COMPLETED
Breast Cancer Metastatic
GBG Forschungs GmbH
2018-03-15 PHASE2
NCT03308201 COMPLETED
Breast Cancer
Tianjin Hemay Pharmaceutical Co., Ltd
2017-10-16 PHASE1
NCT04300790 COMPLETED
Breast Cancer
MedSIR
2020-10-23 PHASE2
NCT03312738 COMPLETED
Advanced Breast Cancer
Novartis Pharmaceuticals
2017-09-15 PHASE2
NCT02648477 COMPLETED
Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Negative; Progesterone Receptor Negative; Progesterone Receptor Positive; Stage IV Breast Cancer; Triple-Negative Breast Carcinoma
City of Hope Medical Center
2016-03-28 PHASE2
NCT02666105 COMPLETED
Non-Small Cell Lung Cancer
Masonic Cancer Center, University of Minnesota
2018-09-27 PHASE2
NCT01870505 COMPLETED
Metastatic or Locally-advanced Unresectable Breast Cancer
Memorial Sloan Kettering Cancer Center
2013-05 PHASE1
NCT04059484 TERMINATED
Breast Cancer Metastatic
Sanofi
2019-10-22 PHASE2
NCT04296565 Recruiting
Mild Cognitive Impairment
VA Office of Research and Development
2022-01-03 Phase 4
NCT03220178 TERMINATED
Breast Neoplasm
Palleos Healthcare GmbH
2017-07-24 PHASE4
NCT02917005 UNKNOWN
Metastatic Breast Cancer
Hamdy A. Azim
2019-05-07 PHASE2
NCT02440230 COMPLETED
Breast Cancer
Shanghai Jiao Tong University School of Medicine
2015-05 PHASE2
NCT03125746 UNKNOWN
Advanced Breast Cancer
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
2017-06-12 PHASE1
NCT03659136 COMPLETED
Breast Neoplasms
Boehringer Ingelheim
2018-11-28 PHASE2
NCT02028364 COMPLETED
Breast Cancer
Jules Bordet Institute
2014-01-12 PHASE2
NCT03538171 UNKNOWN
Advanced Breast Cancer
Taizhou EOC Pharma Co., Ltd.
2018-05-15 PHASE3
NCT02592746 UNKNOWN
Metastatic Breast Cancer
Samsung Medical Center
2016-06 PHASE2
NCT02057133 ACTIVE_NOT_RECRUITING
Breast Neoplasms
Eli Lilly and Company
2014-03-10 PHASE1
NCT02109913 UNKNOWN
Hormone Receptor Positive Malignant Neoplasm of Breast; Metastatic Breast Cancer
Amsterdam UMC, location VUmc
2014-03
NCT04692909 Unknown status
Food Addiction|Obesity Morbid
Soroka University Medical Center
2021-01-15 Not Applicable
NCT02871791 COMPLETED
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Hormone Receptor (HR)-Positive Breast Cancer
Dana-Farber Cancer Institute
2016-08-24 PHASE1; PHASE2
NCT03874325 TERMINATED
Breast Cancer; Hormone Receptor Positive Tumor
H. Lee Moffitt Cancer Center and Research Institute
2019-04-26 PHASE2
NCT04572295 Active not recruiting
Breast Neoplasms
Eisai Co. Ltd.|Eisai Inc.
2020-10-09 Phase 1
NCT02623751 COMPLETED
Breast Cancer
Kyowa Kirin Co., Ltd.
2015-11 PHASE1
NCT03272477 COMPLETED
Breast Neoplasms
Palleos Healthcare GmbH
2017-10-05 PHASE2
NCT00541086 UNKNOWN
Breast Cancer
Gruppo Italiano Mammella (GIM)
2007-03 PHASE3
NCT04659551 COMPLETED
Breast Cancer
Istituto Oncologico Veneto IRCCS
2017-10-05 PHASE2
NCT02115282 ACTIVE_NOT_RECRUITING
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Breast Adenocarcinoma; HER2/Neu Negative; Locally Advanced Breast Carcinoma; Metastatic Breast Carcinoma; Recurrent Breast Carcinoma
National Cancer Institute (NCI)
2014-03-29 PHASE3
NCT03024580 UNKNOWN
Breast Neoplasm
Instituto Nacional de Cancer, Brazil
2017-03-06 PHASE2
NCT02732119 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2016-06-14 PHASE1; PHASE2
NCT03219476 COMPLETED
Breast Cancer; Invasive Breast Cancer
Medical College of Wisconsin
2017-02-05 PHASE2
NCT02258451 COMPLETED
Breast Neoplasms
Bayer
2015-06-04 PHASE2
NCT02517593 COMPLETED
Breast Cancer
Mayo Clinic
2016-03 PHASE1; PHASE2
NCT02646735 UNKNOWN
Breast Cancer
Chinese Academy of Medical Sciences
2015-12 PHASE2
NCT02598557 COMPLETED
Stage 0 Breast Cancer AJCC v6 and v7; Stage I Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7
National Cancer Institute (NCI)
2016-12-06 PHASE2
NCT03361800 TERMINATED
Breast Cancer; Invasive Breast Cancer; ER-Negative PR-Negative HER2-Negative Breast Cancer
UNC Lineberger Comprehensive Cancer Center
2018-11-28 EARLY_PHASE1
NCT00810797 COMPLETED
Breast Cancer
City of Hope Medical Center
2008-12-02 PHASE2
NCT02077933 COMPLETED
Neoplasms; Breast Neoplasms; Kidney Neoplasms; Pancreatic Neuroendocine Neoplasms (pNETs)
Novartis Pharmaceuticals
2014-05-14 PHASE1
NCT03291886 COMPLETED
Advanced or Recurrent Breast Cancer
Kyowa Kirin Co., Ltd.
2017-09-22 PHASE2
NCT01627067 TERMINATED
Breast Cancer
M.D. Anderson Cancer Center
2012-09 PHASE2
NCT02291913 COMPLETED
Breast Cancer
SCRI Development Innovations, LLC
2014-12-18 PHASE2
NCT03176238 COMPLETED
Post Menopausal Breast Cancer
Novartis Pharmaceuticals
2013-03-29 PHASE3
NCT02028507 COMPLETED
Metastatic Breast Cancer
Spanish Breast Cancer Research Group
2014-03-13 PHASE3
NCT01664754 COMPLETED
Stage IV Non-small Cell Lung Cancer
Jonsson Comprehensive Cancer Center
2012-09-07 PHASE1
NCT02689921 UNKNOWN
Breast Neoplasms
Midwestern Regional Medical Center
2016-04 PHASE2
NCT01176916 COMPLETED
Breast Neoplasms
Pfizer
2011-02-09 PHASE4
NCT02820961 COMPLETED
Breast Cancer; Estrogen Receptor Positive Breast Cancer
Syndax Pharmaceuticals
2016-06-29 PHASE1
NCT02983604 TERMINATED
Advanced Estrogen Receptor Positive HER2- Breast Cancer
Gilead Sciences
2017-01-10 PHASE1; PHASE2
NCT02833155 COMPLETED
Breast Cancer
Taizhou EOC Pharma Co., Ltd.
2016-08-29 PHASE1
NCT01783444 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2013-02-26 PHASE2
NCT02049957 COMPLETED
Breast Cancer
Calithera Biosciences, Inc
2014-02-13 PHASE2
NCT01989780 COMPLETED
Metastatic Breast Cancer
Japan Breast Cancer Research Group
2014-01 PHASE2
NCT01638247 COMPLETED
Male Breast Cancer
GBG Forschungs GmbH
2012-08 PHASE3
NCT01857193 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2013-09-06 PHASE1
NCT00310180 ACTIVE_NOT_RECRUITING
Breast Adenocarcinoma; Hormone Receptor Positive; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIB Breast Cancer AJCC v7
National Cancer Institute (NCI)
2006-04-07 PHASE3
NCT02482753 COMPLETED
Breast Cancer
Chipscreen Biosciences, Ltd.
2015-07 PHASE3
NCT02404051 UNKNOWN
Metastatic Breast Cancer; Breast Cancer; Hormone Receptor Positive Tumor; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Locally Advanced Malignant Neoplasm
Consorzio Oncotech
2015-12 PHASE3
NCT01127295 COMPLETED
Hormono-depending Adjuvant Breast Cancer
Institut Claudius Regaud
2010-06-17 PHASE4
NCT02392611 COMPLETED
Solid Tumors and Lymphomas
Gilead Sciences
2015-03-16 PHASE1
NCT01963481 COMPLETED
Metastatic Beast Cancer
NYU Langone Health
2013-09 PHASE2
NCT02467686 UNKNOWN
Sexuality
Irmandade da Santa Casa de Misericordia de Sao Paulo
2014-01 PHASE4
NCT02248571 COMPLETED
Breast Cancer Recurrent; HER2/Neu-negative Carcinoma of Breast; Hormone Receptor Positive Malignant Neoplasm of Breast
iOMEDICO AG
2014-08 PHASE4
NCT01655004 UNKNOWN
Breast Carcinoma
National University Hospital, Singapore
2012-08
NCT02549430 COMPLETED
Breast Cancer
Fondazione Sandro Pitigliani
2012-10 PHASE2
NCT02676986 COMPLETED
Primary Breast Cancer ER+ve; Primary Breast Cancer AR+ve TNBN
Queen Mary University of London
2015-08-10 PHASE2
NCT02123823 COMPLETED
Neoplasms
Boehringer Ingelheim
2014-05-15 PHASE1
NCT02007512 COMPLETED
Breast Cancer
Pfizer
2013-12-16 PHASE2
NCT01743560 COMPLETED
Oestrogen Receptor Positive Advanced Breast Cancer
Novartis Pharmaceuticals
2013-01-31 PHASE4
NCT02025712 UNKNOWN
Hormone Receptor Positive Malignant Neoplasm of Breast
Organisation for Oncology and Translational Research
PHASE2
NCT01938846 COMPLETED
Neoplasms
Boehringer Ingelheim
2013-09-05 PHASE1
NCT01594216 COMPLETED
Estrogen-receptor Positive Invasive Metastatic Breast Cancer
Abramson Cancer Center at Penn Medicine
2012-04 PHASE2
NCT02069093 COMPLETED
Advanced Breast Cancer
Novartis Pharmaceuticals
2014-05 PHASE2
NCT01612871 COMPLETED
Breast Cancer
Institut Claudius Regaud
2012-06-27 PHASE4
NCT01698918 COMPLETED
Hormone Receptor Positive Breast Cancer
Novartis Pharmaceuticals
2013-03-07 PHASE2
NCT01597193 COMPLETED
Breast Cancer
Pfizer
2012-04-30 PHASE1
NCT00941330 COMPLETED
Breast Cancer
Emory University
2009-07 PHASE2
NCT01658176 WITHDRAWN
Breast Neoplasms
Pfizer
2013-01 PHASE2
NCT01720602 COMPLETED
Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
University of Washington
2012-11
NCT00863655 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2009-06-03 PHASE3
NCT00659373 COMPLETED
Breast Cancer; Fatigue; Sleep Disorders
ETOP IBCSG Partners Foundation
2007-12 PHASE3
NCT01760980 WITHDRAWN
Healthy
Actavis Inc.
2012-11 PHASE1
NCT01202591 COMPLETED
FGFR Inhibition, Pharmacokinetics, Biomarkers; ER+ Breast Cancer
AstraZeneca
2010-12 PHASE1; PHASE2
NCT01381874 COMPLETED
Metastatic ER+ Her2- Breast Cancer; Postmenopausal
Janssen Research & Development, LLC
2011-08-24 PHASE2
NCT01773460 TERMINATED
Metastatic Breast Cancer
GBG Forschungs GmbH
2013-07 PHASE3
NCT01431053 UNKNOWN
Breast Neoplasms
Chinese Academy of Medical Sciences
2011-07 PHASE2
NCT01151046 COMPLETED
Her2 Negative Breast Cancer Patients
Merrimack Pharmaceuticals
2010-06 PHASE2
NCT01303679 TERMINATED
First Line Metastatic Breast Cancer
ARCAGY/ GINECO GROUP
2010-06 PHASE3
NCT00066690 COMPLETED
Estrogen Receptor Positive Breast Cancer; Progesterone Receptor Positive Tumor; Recurrent Breast Carcinoma; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer
ETOP IBCSG Partners Foundation
2003-12-17 PHASE3
NCT01594398 COMPLETED
Lung Cancer; Non Small Cell Lung Cancer (NSCLC); Breast Cancer; Estrogen Receptor Breast Cancer
Syndax Pharmaceuticals
2012-05 PHASE1
NCT01605396 COMPLETED
Breast Neoplasms
Merck Sharp & Dohme LLC
2012-07-04 PHASE2
NCT01626222 COMPLETED
Metastatic Breast Cancer
Novartis Pharmaceuticals
2012-06 PHASE3
NCT01234857 COMPLETED
Breast Cancer
Merck Sharp & Dohme LLC
2010-09-17 PHASE2
NCT00688194 UNKNOWN
Breast Cancer
Gruppo Italiano Mammella (GIM)
2008-05 PHASE3
NCT01553903 COMPLETED
Breast Cancer
Institut Claudius Regaud
2011-12 PHASE4
NCT00573755 TERMINATED
Breast Cancer
Mayo Clinic
2007-12 PHASE2
NCT01831076 COMPLETED
Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer
University of Colorado, Denver
2002-04 PHASE2
NCT01385280 COMPLETED
Estrogen Receptor-positive Breast Cancer; Progesterone Receptor Positive Tumor; Recurrent Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
University of Arizona
2011-02
NCT01149356 TERMINATED
Estrogen Receptor Positive; HER2/Neu Negative; Male Breast Carcinoma; Recurrent Breast Carcinoma; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
National Cancer Institute (NCI)
2010-10 PHASE1
NCT01648608 UNKNOWN
Breast Cancer
Tianjin Medical University
2012-01 PHASE2; PHASE3
NCT01231659 COMPLETED
Postmenopausal Women; Locally Advanced Metastatic Breast Cancer; Metastatic Breast Cancer
Novartis Pharmaceuticals
2011-08-09 PHASE2
NCT00615524 WITHDRAWN
Hormone-receptor Positive Breast Cancer
GlaxoSmithKline
2008-04 PHASE2
NCT00372996 TERMINATED
Breast Neoplasms
Pfizer
2007-02 PHASE2
NCT00933309 COMPLETED
Breast Cancer
M.D. Anderson Cancer Center
2009-07 PHASE1
NCT00265759 COMPLETED
Breast Cancer
Alliance for Clinical Trials in Oncology
2006-01 PHASE3
NCT01153672 COMPLETED
Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
University of Washington
2010-11
NCT01240941 WITHDRAWN
Metastatic Breast Cancer
Vanderbilt-Ingram Cancer Center
2011-02 PHASE2
NCT00201864 COMPLETED
Breast Cancer
Ohio State University Comprehensive Cancer Center
2005-09 PHASE2
NCT00684216 TERMINATED
Breast Cancer
The Netherlands Cancer Institute
2008-04 PHASE2; PHASE3
NCT00893061 COMPLETED
Breast Cancer
Centre Oscar Lambret
2009-03-16 PHASE3
NCT00728949 COMPLETED
Metastatic Breast Cancer
Eli Lilly and Company
2008-08 PHASE2
NCT00073073 COMPLETED
Breast Neoplasms
Georgetown University
2003-11 PHASE2
NCT01005641 WITHDRAWN
Breast Cancer
National Cancer Institute, Naples
2009-12 PHASE2
NCT01004081 COMPLETED
Breast Cancer
Biogen
2009-11 PHASE2
NCT00931450 UNKNOWN
Breast Cancer
Institut Català d'Oncologia
2009-03 PHASE1; PHASE2
NCT00194792 TERMINATED
Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Progesterone Receptor-positive Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer
University of Washington
2005-08 PHASE2
NCT00944918 COMPLETED
Progression-free Survival
AstraZeneca
2008-12 PHASE3
NCT00083174 COMPLETED
Breast Cancer
NCIC Clinical Trials Group
2004-12-03 PHASE3
NCT00066703 COMPLETED
Breast Cancer
ETOP IBCSG Partners Foundation
2003-11-03 PHASE3
NCT00354302 COMPLETED
Breast Cancer; Osteoporosis
NCIC Clinical Trials Group
2006-04-24 PHASE3
NCT00767520 COMPLETED
Breast Cancer
Bristol-Myers Squibb
2009-02 PHASE2
NCT00676663 COMPLETED
Breast Cancer; Estrogen Receptor-Positive Breast Cancer; Breast Cancer, Estrogen Receptor-Positive; ER+ Breast Cancer
Syndax Pharmaceuticals
2008-06-13 PHASE2
NCT00905021 TERMINATED
Metastatic Breast Cancer
Baylor Breast Care Center
2010-03 PHASE1; PHASE2
NCT00143390 COMPLETED
Breast Neoplasms
Pfizer
2005-04 PHASE3
NCT00066573 COMPLETED
Breast Cancer
NCIC Clinical Trials Group
2003-06-06 PHASE3
NCT00432172 COMPLETED
Breast Cancer
Spanish Breast Cancer Research Group
2007-04-24 PHASE2
NCT00902954 UNKNOWN
Breast Cancer
Fudan University
2008-03 PHASE3
NCT00793546 TERMINATED
Advanced Breast Cancer
Pfizer
2009-02 PHASE2
NCT00626106 COMPLETED
Breast Cancer; Breast Tumors; Metastatic Cancer
NantCell, Inc.
2008-03-27 PHASE2
NCT00687648 UNKNOWN
Breast Cancer
National Cancer Centre, Singapore
2008-05 PHASE2
NCT00417885 TERMINATED
Breast Neoplasms
Pfizer
2007-06 PHASE1; PHASE2
NCT01965080 COMPLETED
Endometrial Cancer
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
2004-03 PHASE2
NCT00279448 COMPLETED
Breast Neoplasms
Pfizer
2002-01 PHASE3
NCT00036270 COMPLETED
Breast Neoplasms
Pfizer
2001-08 PHASE3
NCT00038103 COMPLETED
Breast Neoplasms
Pfizer
2002-01 PHASE2
NCT01237327 COMPLETED
Metastatic Breast Cancer
Pfizer
2001-11 PHASE3
NCT00066586 COMPLETED
Breast Cancer
NCIC Clinical Trials Group
2001-08-01
NCT00201773 COMPLETED
Breast Cancer
Ohio State University Comprehensive Cancer Center
2003-07 PHASE2
NCT00261027 COMPLETED
Ovarian Cancer
Ottawa Hospital Research Institute
2003-01 PHASE2
NCT00649090 COMPLETED
Breast Neoplasms
Pfizer
2005-03 PHASE4
NCT00066807 TERMINATED
Breast Cancer
ETOP IBCSG Partners Foundation
2003-08 PHASE3
NCT00040014 TERMINATED
Breast Neoplasms
Pfizer
2002-06 PHASE2
NCT00919399 COMPLETED
Breast Neoplasms
Institut Claudius Regaud
2002-01 PHASE2
NCT00065325 COMPLETED
Locally Advanced Breast Cancer; Metastatic Breast Cancer
AstraZeneca
2003-08 PHASE3
NCT00128843 COMPLETED
Breast Cancer
Spanish Breast Cancer Research Group
2001-08 PHASE2
NCT00525096 COMPLETED
Metastatic Breast Cancer
ARCAGY/ GINECO GROUP
2003-07 PHASE3
NCT01331434 COMPLETED
Breast Cancer
Roxane Laboratories
2004-10
NCT00057993 WITHDRAWN
Breast Cancer
Northwestern University
2002-07 PHASE2
NCT01331421 COMPLETED
Breast Cancer
Roxane Laboratories
2004-07
NCT01331447 COMPLETED
Breast Cancer
Roxane Laboratories
2004-05
NCT00016432 COMPLETED
Breast Cancer
NSABP Foundation Inc
2001-05 PHASE3
NCT00200174 COMPLETED
Breast Cancer
Memorial Sloan Kettering Cancer Center
1999-07
NCT00038467 COMPLETED
Breast Neoplasms
Pfizer
1998-02 PHASE3
NCT00002777 COMPLETED
Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTC
1996-05 PHASE3
NCT00031889 COMPLETED
Prostate Cancer
Swiss Cancer Institute
2001-08 PHASE2
NCT00010010 COMPLETED
Breast Cancer
NYU Langone Health
2000-06 PHASE2
NCT00174343 COMPLETED
Breast Neoplasms
Pfizer
2001-11 PHASE2
NCT00291798 COMPLETED
Breast Cancer
Austrian Breast & Colorectal Cancer Study Group
2000-09 PHASE2
NCT00674557 TERMINATED
Breast Cancer
Cancer Research UK
2008-06 PHASE2
NCT00032136 COMPLETED
Breast Cancer
Cancer Research Campaign Clinical Trials Centre
2001-12 PHASE3
NCT00003418 UNKNOWN
Breast Cancer
International Collaborative Cancer Group
1998-02 PHASE3
NCT00810706 TERMINATED
Breast Cancer
Hellenic Breast Surgeons Society
2001-04 PHASE3
NCT00080613 WITHDRAWN
Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
Robert H. Lurie Cancer Center
PHASE2
NCT01240928 WITHDRAWN
Metastatic Breast Cancer
Vanderbilt-Ingram Cancer Center
PHASE1

(data from https://clinicaltrials.gov, updated on 2025-09-29)

Check the Exemestane product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Exemestane acts as an irreversible, steroidal suicide inhibitor of the aromatase enzyme, binding to the active site as a false substrate to permanently block the conversion of androgen precursors into estrogens. This selective depletion of systemic estrogen levels deprives hormone receptor-positive tumor cells of essential growth signals, thereby inhibiting cellular proliferation in advanced and metastatic breast cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.