Elacestrant
- Generic Name
- Elacestrant
- Brand Names
- Orserdu
- Drug Type
- Small Molecule
- Chemical Formula
- C30H38N2O2
- CAS Number
- 722533-56-4
- Unique Ingredient Identifier
- FM6A2627A8
- Background
Elacestrant is a non-steroidal small molecule and an estrogen receptor (ER) antagonist. In January 2023, it was approved by the FDA for the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. Elacestrant binds to estrogen receptor-alpha (ERα) and acts as a selective estrogen receptor degrader (SERD) thanks to its ability to block the transcriptional activity of the ER and promote its degradation. Other types of endocrine therapy, such as selective estrogen receptor modulators (SERMs) and aromatase inhibitors (AIs), may lead to drug resistance over time; therefore, the use of a SERD represents a therapeutic approach for the treatment of endocrine-resistant breast cancers. Unlike fulvestrant, another FDA-approved SERD, elacestrant is orally bioavailable.
- Indication
Elacestrant is indicated for the treatment of postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
- Associated Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
- Conditions
- Breast CancerMetastatic Breast CancerLocally Advanced Breast Cancer
- Interventions
- First Posted Date
- 2023-07-27
- Last Posted Date
- 2025-05-11
- Lead Sponsor
- Carrick Therapeutics Limited
- Target Recruit Count
- 48
- Registration Number
- NCT05963997
- Locations
- 🇺🇸
Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, United States
🇺🇸Site 42 - Dana-Farber Cancer Institute, EDDC, Boston, Massachusetts, United States
🇺🇸Site 35 - Cleveland Clinic, Taussig Cancer Institute, Cleveland, Ohio, United States
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
- First Posted Date
- 2022-11-16
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- Context Therapeutics Inc.
- Target Recruit Count
- 4
- Registration Number
- NCT05618613
- Locations
- 🇺🇸
Cancer Treatment Centers of America - Western Regional Medical Center, Phoenix, Arizona, United States
🇺🇸Sarah Cannon Research Institute, Nashville, Tennessee, United States
🇺🇸Cancer Treatment Centers of America - Midwestern Regional Center, Zion, Illinois, United States
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
- First Posted Date
- 2022-10-27
- Last Posted Date
- 2025-03-26
- Lead Sponsor
- Stemline Therapeutics, Inc.
- Target Recruit Count
- 80
- Registration Number
- NCT05596409
- Locations
- 🇬🇪
Todua Clinic, Tbilisi, Georgia
🇺🇸Northwestern University, Northwestern Feinberg School of Medicine Prentice Women's Hospital, Chicago, Illinois, United States
🇲🇽I CAN Oncology Center, Centro Medico AVE, Monterrey, Nuevo Leon, Mexico
Phase 1/2 Study to Evaluate Vosilasarm (EP0062) as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
- Conditions
- Metastatic Breast CancerHormone Receptor Positive HER-2 Negative Breast CancerHormone Receptor-positive Breast Cancer
- Interventions
- First Posted Date
- 2022-10-10
- Last Posted Date
- 2025-02-21
- Lead Sponsor
- Ellipses Pharma
- Target Recruit Count
- 60
- Registration Number
- NCT05573126
- Locations
- 🇪🇸
Hospital 12 de Octubre, Madrid, Spain
🇪🇸NEXT Oncology Hospital Quironsalud, Madrid, Spain
🇬🇧The Clatterbridge Cancer Centre, Liverpool, United Kingdom
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
- Conditions
- Breast CancerMetastatic Breast Cancer
- Interventions
- First Posted Date
- 2022-10-03
- Last Posted Date
- 2025-05-02
- Lead Sponsor
- Stemline Therapeutics, Inc.
- Target Recruit Count
- 400
- Registration Number
- NCT05563220
- Locations
- 🇺🇸
Dothan Hematology and Oncology, Dothan, Alabama, United States
🇺🇸Mayo Clinic - Arizona, Phoenix, Arizona, United States
🇺🇸Highlands Oncology Group, Springdale, Arkansas, United States
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
- Conditions
- HER2-negative Breast CancerStage IIB Breast CancerStage III Breast CancerER-positive Breast Cancer
- Interventions
- First Posted Date
- 2022-08-23
- Last Posted Date
- 2024-01-24
- Target Recruit Count
- 220
- Registration Number
- NCT05512364
- Locations
- 🇧🇪
Institut Jules Bordet, Anderlecht, Belgium
🇧🇪Pole Hospitalier Jolimont - Hopital Jolimont, Haine-Saint-Paul, Belgium
🇧🇪CHU Site Sainte-Elisabeth-UCL Namur, Namur, Belgium
Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to ER+/HER-2- Breast Cancer
- Conditions
- Neoplasms by SiteNeoplasmsBrain DiseasesBrain NeoplasmsCentral Nervous System NeoplasmsCentral Nervous System DiseasesBreast NeoplasmsBreast Diseases
- Interventions
- First Posted Date
- 2022-05-23
- Last Posted Date
- 2025-05-07
- Lead Sponsor
- Stemline Therapeutics, Inc.
- Target Recruit Count
- 68
- Registration Number
- NCT05386108
- Locations
- 🇺🇸
Providence Medical Foundation, Fullerton, California, United States
🇺🇸California Research Institute, Los Angeles, California, United States
🇺🇸Carle Cancer Center, Urbana, Illinois, United States
Elacestrant in Preoperative Setting, a Window of Opportunity Study
- Conditions
- Breast CancerHormone Receptor Positive Breast Carcinoma
- Interventions
- First Posted Date
- 2021-03-15
- Last Posted Date
- 2022-10-26
- Lead Sponsor
- SOLTI Breast Cancer Research Group
- Target Recruit Count
- 23
- Registration Number
- NCT04797728
- Locations
- 🇪🇸
Hospital Clinic Barcelona, Barcelona, Spain
🇪🇸Hospital Universitari Vall d'Hebron, Barcelona, Spain
🇪🇸Hospital General de Catalunya, Sant Cugat Del Vallès, Barcelona, Spain
Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer
- First Posted Date
- 2021-03-10
- Last Posted Date
- 2023-07-27
- Lead Sponsor
- Criterium, Inc.
- Target Recruit Count
- 44
- Registration Number
- NCT04791384
- Locations
- 🇺🇸
Cancer Care Northwest, Spokane Valley, Washington, United States
🇺🇸Duke Cancer Center, Durham, North Carolina, United States
🇺🇸University of Colorado, Aurora, Colorado, United States
Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer
- First Posted Date
- 2018-12-19
- Last Posted Date
- 2024-10-30
- Lead Sponsor
- Stemline Therapeutics, Inc.
- Target Recruit Count
- 478
- Registration Number
- NCT03778931
- Locations
- 🇺🇸
Dayton Oncology & Hematology, Kettering, Ohio, United States
🇺🇸Keck Medical Center of USC, Los Angeles, California, United States
🇺🇸UCLA Hematology/Oncology, Los Angeles, California, United States
Drug Development Updates
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