Drugs / Exemestane
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Exemestane

Small molecule targets CYP19A1 via inhibition

Developed for
breast cancer · female breast carcinoma · hormone receptor-positive breast cancer · estrogen-receptor positive breast cancer · breast neoplasm · Her2-receptor negative breast cancer · HER2 positive breast carcinoma · progesterone-receptor positive breast cancer
+30 more · invasive breast carcinoma · breast carcinoma · male breast carcinoma · breast carcinoma in situ · endometrial cancer · metastatic malignant neoplasm · non-small cell lung carcinoma · ovarian cancer · atypical endometrial hyperplasia · breast adenocarcinoma · breast lobular carcinoma · cancer · endometrial carcinoma · endometrial endometrioid adenocarcinoma · exocrine pancreatic carcinoma · metastatic carcinoma in the bone · ovarian carcinoma · ovarian granulosa cell tumor · polycystic ovary syndrome · prostate carcinoma · salivary gland carcinoma · sarcoma · secondary malignant neoplasm · urinary bladder cancer · urothelial carcinoma · uterine corpus endometrial stromal sarcoma · basal-like breast carcinoma · ductal breast carcinoma in situ · luminal B breast carcinoma · prostate cancer
Investigated by
National Cancer Institute (NCI) · Pfizer · Novartis Pharmaceuticals · Fudan University · ETOP IBCSG Partners Foundation · Eli Lilly and Company
+155 more · UNICANCER · Breast International Group · Cancer and Leukemia Group B · AstraZeneca · City of Hope Medical Center · Dana-Farber Cancer Institute · Institut Claudius Regaud · Merck Sharp & Dohme LLC · NCIC Clinical Trials Group · Agendia · Breast Cancer Research Foundation · Clinical Research Technology S.r.l. · Emory University · European Organisation for Research and Treatment of Cancer - EORTC · GBG Forschungs GmbH · Genentech, Inc. · Georgetown University · International Collaborative Cancer Group · M.D. Anderson Cancer Center · Medical College of Wisconsin · Memorial Sloan Kettering Cancer Center · NSABP Foundation Inc · NYU Langone Health · North Central Cancer Treatment Group · Novartis · Ohio State University Comprehensive Cancer Center · Ottawa Hospital Research Institute · Peking University Cancer Hospital & Institute · Roche Pharma AG · SWOG Cancer Research Network · Spanish Breast Cancer Research Group · Sun Yat-sen University · Susan G. Komen Breast Cancer Foundation · Tianjin Hemay Pharmaceutical Co., Ltd · University of Ulm · University of Washington · iOMEDICO AG · AMS Advanced Medical Services GmbH · ARCAGY/ GINECO GROUP · Abramson Cancer Center at Penn Medicine · Alliance for Clinical Trials in Oncology · Amgen · Amsterdam UMC, location VUmc · Andrea DeCensi · Anhui Provincial Cancer Hospital · Arbeitsgemeinschaft fur Internistische Onkologie · Astellas Pharma Inc · Baylor Breast Care Center · Breast Cancer Trials, Australia and New Zealand · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Calithera Biosciences, Inc · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Cancer Research Campaign Clinical Trials Centre · Cancer Research UK · Cankado GmbH · Catalan Institute of Oncology · Celgene Corporation · Centre Leon Berard · Centre Oscar Lambret · Chinese Academy of Medical Sciences · Chinese PLA General Hospital · Chugai Pharmaceutical · Consorzio Oncotech · Dana-Farber/Brigham and Women's Cancer Center · Dartmouth-Hitchcock Medical Center · Dutch Breast Cancer Research Group · Eastern Cooperative Oncology Group · Eisai Inc. · Ente Ospedaliero Ospedali Galliera · European Institute of Oncology · Federation of Italian Cooperative Oncology Groups · First Affiliated Hospital of Zhejiang University · First Affiliated Hospital, Sun Yat-Sen University · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · all 161 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) AROMASIN — 2005-10-05 – 2016-07-25 fda.gov ↗
Approved US (FDA) AROMASIN — 1999-10-21 fda.gov ↗

Trials 172 · started per year

today
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199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 116 trials
Phase 1 NCT07706374 Oct 2026 → Dec 2028 expected polycystic ovary syndrome University of North Carolina, Chapel Hill Recruiting No outcome recorded
Phase 1 NCT07369505 Dec 2025 → Jun 2026 overdue breast carcinoma, hepatocellular carcinoma, neuroendocrine neoplasm, renal cell carcinoma +1 SAPU NANO (US) LLC Recruiting No outcome recorded
Phase 1 NCT07163481 Oct 2025 → Dec 2026 expected female breast carcinoma Hunan Cancer Hospital Not yet recruiting No outcome recorded
Phase 1 NCT03554044 Feb 2020 → Dec 2023 Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, invasive breast carcinoma University of California, San Francisco Completed No outcome recorded
Phase 1 NCT04188548 Dec 2019 → Jun 2020 overdue breast cancer, endometrial cancer Eli Lilly and Company Active not recruiting No outcome recorded
Phase 1 NCT03959891 May 2019 → Dec 2022 overdue breast cancer Massachusetts General Hospital Active not recruiting No outcome recorded
Phase 1 NCT03308201 Oct 2017 → Jun 2022 breast cancer Tianjin Hemay Pharmaceutical Co., Ltd Completed No outcome recorded
Phase 1 NCT03125746 Jun 2017 → Oct 2021 breast cancer Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. Unknown No outcome recorded
Phase 1 NCT02833155 Aug 2016 → Jul 2018 breast cancer Taizhou EOC Pharma Co., Ltd. Completed No outcome recorded
Phase 1 NCT02077933 May 2014 → Apr 2019 breast neoplasm, kidney neoplasm, pancreatic neuroendocrine tumor Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/28 trials · 1 met primary · 1 missed
Phase 1/2 NCT03280563 Dec 2017 → Sep 2024 breast neoplasm Hoffmann-La Roche Completed Missed primary
Phase 1/2 NCT02990845 Sep 2017 → Aug 2022 breast carcinoma National Taiwan University Hospital Terminated Met primary
Phase 1/2 NCT02871791 Aug 2016 → Dec 2020 hormone receptor-positive breast cancer Dana-Farber Cancer Institute Completed No outcome recorded
Phase 1/2 NCT02732119 Jun 2016 → Feb 2020 breast cancer Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT01484041 Apr 2012 → Dec 2015 breast cancer Georgetown University Terminated No outcome recorded
Phase 1/2 NCT00905021 Mar 2010 → Jan 2011 breast cancer Baylor Breast Care Center Terminated No outcome recorded
Phase 1/2 NCT00931450 Mar 2009 → Oct 2011 breast cancer Catalan Institute of Oncology Unknown No outcome recorded
Phase 1/2 NCT00417885 Jun 2007 → Jul 2009 breast cancer Pfizer Terminated No outcome recorded
Phase 291 trials · 4 met primary · 4 missed
Phase 2 NCT07826052 Sep 2026 → Sep 2031 expected breast cancer Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT07796880 Sep 2026 → Sep 2028 expected hormone receptor-positive breast cancer Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting No outcome recorded
Phase 2 NCT07499999 Sep 2026 → Aug 2027 expected ATM-related cancer predisposition, BRCA2-related cancer predisposition, CHEK2-related cancer predisposition, atypical lobular breast hyperplasia +1 Dana-Farber Cancer Institute Not yet recruiting No outcome recorded
Phase 2 NCT07618923 Jun 2026 → Jun 2028 expected hormone receptor-positive breast cancer Tang-Du Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07395336 May 2026 → Dec 2028 expected breast cancer European Institute of Oncology Recruiting No outcome recorded
Phase 2 NCT07527806 May 2026 → May 2029 expected breast cancer Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT07483307 Mar 2026 → Mar 2030 expected Her2-receptor negative breast cancer, breast lobular carcinoma, estrogen-receptor positive breast cancer Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT07300215 Dec 2025 → Nov 2027 expected breast cancer The First Affiliated Hospital of Bengbu Medical University Not yet recruiting No outcome recorded
Phase 2 NCT07299890 Dec 2025 → Nov 2027 expected breast cancer Anhui Provincial Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06364267 Oct 2025 → Jan 2027 expected breast cancer Andrea DeCensi Recruiting No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT06009627 Apr 2023 → Mar 2025 breast cancer Tianjin Medical University Cancer Institute and Hospital Completed No outcome recorded
Phase 2/3 NCT05253066 Feb → Jul 2022 breast neoplasm Shengjing Hospital Unknown No outcome recorded
Phase 2/3 NCT01648608 Jan → Dec 2012 breast cancer Tianjin Medical University Unknown No outcome recorded
Phase 340 trials · 5 met primary · 12 missed
Phase 3 NCT07153757 Sep 2025 → Sep 2033 expected female breast carcinoma Fudan University Not yet recruiting No outcome recorded
Phase 3 NCT07005557 Jun 2025 → May 2030 expected breast cancer Fudan University Not yet recruiting No outcome recorded
Phase 3 NCT06223698 May 2025 → May 2032 expected breast cancer Region Örebro County Not yet recruiting No outcome recorded
Phase 3 NCT06492616 Sep 2024 → Aug 2029 expected breast cancer Stemline Therapeutics, Inc. Recruiting No outcome recorded
Phase 3 NCT06380751 Aug 2024 → Dec 2029 expected breast cancer AstraZeneca Recruiting No outcome recorded
Phase 3 NCT06507618 Jul 2024 → Jun 2029 expected female breast carcinoma University of Virginia Recruiting No outcome recorded
Phase 3 NCT06313983 Jan 2022 → Dec 2025 overdue breast cancer Tianjin Hemay Pharmaceutical Co., Ltd Recruiting No outcome recorded
Phase 3 NCT04975308 Oct 2021 → Jun 2024 overdue breast cancer, metastatic malignant neoplasm Eli Lilly and Company Active not recruiting No outcome recorded
Phase 3 NCT04460807 Feb 2020 → Apr 2023 ovarian cancer Ente Ospedaliero Ospedali Galliera Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT03137368 Aug 2018 → Oct 2023 — Cancer Institute and Hospital, Chinese Academy of Medical Sciences Unknown No outcome recorded
Phase 49 trials
Phase 4 NCT05362760 Apr 2022 → Apr 2029 expected hormone receptor-positive breast cancer University of Ulm Recruiting No outcome recorded
Phase 4 NCT03948568 Sep 2019 → Jun 2021 female breast carcinoma Ottawa Hospital Research Institute Completed No outcome recorded
Phase 4 NCT03238703 Sep 2018 → Mar 2023 Her2-receptor negative breast cancer, breast carcinoma in situ, female breast carcinoma, invasive breast carcinoma Fred Hutchinson Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT03355157 Mar 2018 → Aug 2024 breast cancer GBG Forschungs GmbH Completed No outcome recorded
Phase 4 NCT02248571 Aug 2014 → Aug 2017 female breast carcinoma, hormone receptor-positive breast cancer iOMEDICO AG Completed No outcome recorded
Phase 4 NCT01743560 Jan 2013 → Aug 2016 estrogen-receptor positive breast cancer Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT01553903 Dec 2011 → May 2013 breast cancer Institut Claudius Regaud Completed No outcome recorded
Phase 4 NCT01176916 Feb 2011 → Nov 2018 breast neoplasm Pfizer Completed No outcome recorded
Phase 4 NCT01127295 Jun 2010 → Dec 2017 hormone receptor-positive breast cancer Institut Claudius Regaud Completed No outcome recorded
Phase not applicable5 trials
— NCT06235931 Feb 2024 → Dec 2025 overdue breast neoplasm Second Affiliated Hospital of Soochow University Recruiting No outcome recorded
— NCT02109913 Mar 2014 → Jan 2021 hormone receptor-positive breast cancer Amsterdam UMC, location VUmc Unknown No outcome recorded
— NCT01720602 Nov 2012 → Mar 2015 male breast carcinoma University of Washington Completed No outcome recorded
— NCT01655004 Aug 2012 → Jun 2017 breast carcinoma National University Hospital, Singapore Unknown No outcome recorded
— NCT01385280 Feb 2011 → Jan 2013 estrogen-receptor positive breast cancer, female breast carcinoma, progesterone-receptor positive breast cancer University of Arizona Completed No outcome recorded
Comparator or background therapy152 trials
Phase 0 NCT04088032 Background Oct 2019 → Dec 2020 female breast carcinoma, hormone receptor-positive breast cancer Alison Stopeck Withdrawn No outcome recorded
Phase 1 NCT06218303 Background Feb 2024 → Aug 2026 overdue ductal breast carcinoma in situ Finn, Olivera, PhD Recruiting No outcome recorded
Phase 1 NCT05307705 Background May 2022 → Dec 2026 expected breast cancer Eli Lilly and Company Recruiting No outcome recorded
Phase 1 NCT04572295 Background Oct 2020 → Jun 2026 breast neoplasm Eisai Inc. Completed No outcome recorded
Phase 1 NCT03846583 Background Jun → Sep 2020 breast cancer Dana-Farber Cancer Institute Withdrawn No outcome recorded Stop: Enrollment
Show all 152 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 11

DateIssuerRelease
2021-12-08 Taizhou EOC Pharma Co., Ltd. Results 亿腾景昂1类新药III期临床研究入选第44届SABCS eocpharma.com ↗
结果显示,恩替诺特联合依西美坦治疗可显著改善激素受体阳性乳腺癌患者无进展生存期,在客观应答率和疾病控制率等方面优于依西美坦单药治疗,且患者安全性和耐受性良好。
2021-11-20 Taizhou EOC Pharma Co., Ltd. Results 亿腾景昂临床III期研究成果入选第44届圣安东尼奥乳腺癌大会(SABCS) eocpharma.com ↗
结果显示,恩替诺特联合依西美坦对比安慰剂联合依西美坦可以显著改善经内分泌治疗失败的HR阳性、HER-2阴性晚期乳腺癌患者的PFS,差异具有统计学显著性,且患者安全性和耐受性良好。
2020-05-21 Syndax Pharmaceuticals Results ECOG-ACRIN Provides Syndax Pharmaceuticals With Results of Phase 3 E2112 Trial of Entinostat Plus Exemestane in Patients with HR+, HER2- Breast Cancer syndax.com ↗
The trial did not achieve the primary endpoint of demonstrating a statistically significant overall survival (OS) benefit over hormone therapy alone.
2019-12-03 Great Novel Therapeutics Biotech & Medicals Corporation Regulatory 西達本胺晚期乳癌第二適應症 中國獲批 com.tw ↗
11月29日,「西達本胺」聯合諾曼癌素 (exemestane, aromasin®)用於治療既往內分泌療法失敗或復發的賀爾蒙受體陽性(ER+)、Her-2陰性不可手術晚期乳癌適應症,已經獲得中國NMPA批准取得藥證。
2019-04-29 Great Novel Therapeutics Biotech & Medicals Corporation Results 西達本胺樞紐三期結果正面 榮登刺胳針腫瘤學期刊 com.tw ↗
他指出,從本次研究結果顯示,試驗組與對照組相比,中位的PFS值分別為7.4個月和3.8個月,具有統計顯著差異。
2018-10-25 Syndax Pharmaceuticals Results Syndax to Host Conference Call to Provide Update on the Phase 3 Breast Cancer Trial (E2112) and to Announce its Registration Trial of Entinostat with Keytruda in PD-(L)1 Refractory Non-Small Cell Lung Cancer syndax.com ↗
The trial did not achieve the statistical hurdle for the first primary endpoint of improving progression-free survival (PFS) that would have provided the earliest regulatory filing opportunity.
2018-10-22 Great Novel Therapeutics Biotech & Medicals Corporation Results 西達本胺晚期乳癌樞紐三期 中國解盲達標 com.tw ↗
達到臨床試驗設計的主要療效指標終點、以及安全性符合預期。
2018-10-05 Zydus Lifesciences Limited Regulatory Zydus receives final approval from the USFDA for Exemestane Tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Exemestane Tablets, (US RLD – AROMASIN ® Tablets), 25 mg.
2017-08-24 Novartis Pharmaceuticals Regulatory Novartis Kisqali® (ribociclib) receives EU approval as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor novartis.com ↗
2017-06-23 Novartis Pharmaceuticals Regulatory Novartis Kisqali® (ribociclib) receives positive CHMP opinion as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor novartis.com ↗
The CHMP recommendation of combining Kisqali with any aromatase inhibitor means that, if approved, oncologists could prescribe Kisqali with letrozole, anastrozole or exemestane, giving them the discretion to select the therapy they believe is most appropriate for each individual patient.
2017-04-17 Chipscreen Biosciences, Ltd. Regulatory Phase III clinical trial of breast cancer approved by Taiwan TFDA in Chidamide chipscreen.com ↗
the application of Chidamide combined with aromasin? for the third phase of clinical trials of advanced breast cancer with hormone receptor positive and HER-2 negative was approved by Taiwan TFDA on April 07, 2017

All press releases naming this drug 12 releases

DateIssuerRelease

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 327 sources stand behind the page.

FieldValueCited text
Known as exemestane “Aromatase inhibitor (anastrozole or exemestane or letrozole) oral daily tablet, or Selective Estrogen Receptor Modulator (SERM) such as tamoxifen oral daily tablet or...” NCT03820830 ↗
322

“This treatment consisted of any aromatase inhibitor (e.g. letrozole or exemestane), administered intravenously in Cohort A Groups daily for either 18 (if 6 doses of WT1...” NCT01220128 ↗

“Options include tamoxifen (20 mg daily), aromatase inhibitors (letrozole 2.5 mg daily, anastrozole 1 mg daily, or exemestane 25 mg daily), or fulvestrant (500 mg...” NCT07708194 ↗

“Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of...” NCT01446159 ↗

“Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or...” NCT03204734 ↗

“Letrozole:2.5mg,q4w or Anastrozole:1mg,q4w or Exemestane:25mg,q4w or Fulvestrant:Patients will receive intramuscular Fulvestrant on day 1 and day 15 of the first cycle and then...” NCT07810088 ↗

“Endocrine therapy (physician's choice based on prior administered agent including tamoxifen, exemestane, fulvestrant, anastrozole, or letrozole). Endocrine therapy must be...” NCT03184090 ↗

“Tamoxifen 20 mg daily, or letrozole 2.5 mg daily, or anastrozole 1 mg daily, or exemestane 25 mg daily (male patients will be treated with tamoxifen 20 mg daily) for a total...” NCT03081234 ↗

“Postmenopausal patients: Letrozole (2.5 mg, orally, once daily, for 5 years) or Anastrozole (1 mg, orally, once daily, for 5 years) or Exemestane (25 mg, orally, once daily,...” NCT07153757 ↗

“Subjects will receive standard therapy with an aromatase inhibitor (exemestane, anastrozole, or letrozole), combined with the experimental treatment of abemaciclib and durvalumab” NCT04088032 ↗

“Letrozole 2.5 mg by mouth daily, or anastrozole 1 mg by mouth daily, exemestane 25 mg by mouth daily, tamoxifen 20 mg by mouth daily, for a total duration of at least 60 months.” NCT03078751 ↗

Show 312 more sources

Known as Aromasin “A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal...” NCT00649090 ↗
8

“aromatase inhibitors ( letrozole 2.5 mg PO per day or Anastrozole 1 mg PO per day or aromasin 25 mg PO per day) if post-menopausal, if premenopausal leutnising hormone...” NCT04012918 ↗

“Endocrine Therapy: Exemestane (Aromasin®), Letrozole (Femara®), or Anastrozole (Arimidex®)” NCT03846583 ↗

“A commercial supply of exemestane (Aromasin) will be provided.” NCT00261027 ↗

“IM or Oral Exemestane (Aromasin) in Postmenopausal Women” NCT00040014 ↗

“Aromasin® (exemestane) 25 mg/day PO” NCT00828854 ↗

“exemestane (Aromasin®)” NCT00508586 ↗

“exemestane (Aromasin®)” NCT00174343 ↗

NCT01176916 ↗

Known as Aromasin (exemestane) “Aromasin (exemestane)” NCT00240071 ↗
1

“Aromasin (exemestane)” NCT01897441 ↗

Known as Aromasin, exemestane, Pfizer “Aromasin®, exemestane, Pfizer” NCT00935558 ↗
Known as Baby Exemestane “Randomized Double Blind Phase II Trial of Baby Exemestane vs Baby Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.” NCT06364267 ↗
Known as babyexe “The purpose of the study is to to compare low dose of exemestane (babyexe) versus low dose of tamoxifen (babytam) in terms of change of quality of life from baseline to 12 months.” NCT06364267 ↗
Known as EXE “We hypothesized that exemestane (EXE) would reduce mammographic breast density and have unique effects on biomarkers of bone and lipid metabolism.” PMID 21221773 ↗ Jan 2011
Known as Exemestane (Aromasin) “Exemestane (Aromasin)” NCT06218303 ↗
Known as Exemestane Tablets “Drug: Exemestane Tablets” NCT04906395 ↗
Known as Exemestano ChEMBL registry synonym — accepted as the source's own label CHEMBL1200374 ↗
Known as FCE-24304 ChEMBL registry synonym — accepted as the source's own label CHEMBL1200374 ↗
Known as NSC-758907 ChEMBL registry synonym — accepted as the source's own label CHEMBL1200374 ↗
Known as PNU-155971 ChEMBL registry synonym — accepted as the source's own label CHEMBL1200374 ↗
Action Inhibit “Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.” NCT00002777 ↗
1

“Cytochrome P450 19A1 inhibitor” CHEMBL1200374 ↗

Modality Small molecule “the steroidal aromatase inactivator exemestane versus the antiestrogen tamoxifen” PMID 18794551 ↗ Sep 2008
Route Oral “Patients were randomly assigned to receive exemestane 25 mg or tamoxifen 20 mg orally once daily until disease progression or unacceptable toxicity occurred.” PMID 18794551 ↗ Sep 2008
Target CYP19A1 “Cytochrome P450 19A1 inhibitor” CHEMBL1200374 ↗