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)
Mechanism and Biochemical Profile
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>).