Elacestrant

Generic Name: Elacestrant

Brand Names: Orserdu

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₃₈N_₂O_₂

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

Clinical Trials

A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer

Phase 1

Withdrawn

Conditions: Breast Cancer

Interventions: Drug: Elacestrant
Drug: Onapristone

First Posted Date: 2025-04-22

Last Posted Date: 2025-04-22

Lead Sponsor: Context Therapeutics Inc.

Registration Number: NCT06938711

Locations: 🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States

Circulating Tumor DNA: TBCRC-068

Phase 2

Not yet recruiting

Conditions: ER+ Breast Cancer

Interventions: Drug: Elacestrant

First Posted Date: 2025-04-11

Last Posted Date: 2025-04-11

Lead Sponsor: Yale University

Target Recruit Count: 50

Registration Number: NCT06923527

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States

Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer

Phase 1

Recruiting

Conditions: Breast Cancer Metastatic Breast Cancer
HER2-negative Breast Cancer

Interventions: Drug: Elacestrant
Biological: DC1 native/mutated ESR1

First Posted Date: 2024-11-15

Last Posted Date: 2025-05-07

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 18

Registration Number: NCT06691035

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

Phase 1

Recruiting

Conditions: Advanced Breast Cancer

Interventions: Drug: MEN2312
Drug: Elacestrant

First Posted Date: 2024-10-15

Last Posted Date: 2025-05-07

Lead Sponsor: Stemline Therapeutics, Inc.

Target Recruit Count: 124

Registration Number: NCT06638307

Locations: 🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

and more 16 locations

Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC

Recruiting

Conditions: ESR1 Gene Mutation
Advanced Breast Cancer
Safety

Interventions: Drug: ELacestrant

First Posted Date: 2024-08-09

Last Posted Date: 2024-08-09

Lead Sponsor: SciClone Pharmaceuticals

Target Recruit Count: 350

Registration Number: NCT06544577

Locations: 🇨🇳
Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan), Qionghai, Hainan, China

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

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Elacestrant
Drug: Anastrozole
Drug: Letrozole
Drug: Exemestane
Drug: Tamoxifen

First Posted Date: 2024-07-09

Last Posted Date: 2025-05-21

Lead Sponsor: Stemline Therapeutics, Inc.

Target Recruit Count: 4220

Registration Number: NCT06492616

Locations: 🇪🇸
Hospital Beata Maria Ana, Madrid, Spain
🇺🇸
Southern Cancer Center, PC, Daphne, Alabama, United States
🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

and more 169 locations

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

Phase 3

Recruiting

Conditions: HER2-negative Breast Cancer
Advanced Breast Cancer
ESR1 Gene Mutation
ER-positive Breast Cancer

Interventions: Drug: Everolimus
Drug: Placebo
Drug: Elacestrant
Drug: Auxiliary Medicinal Product - Dexamethasone
Drug: Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues

First Posted Date: 2024-04-24

Last Posted Date: 2025-04-23

Lead Sponsor: MedSIR

Target Recruit Count: 240

Registration Number: NCT06382948

Locations: 🇬🇷
Aretaeio Hospital, Athens, Greece
🇮🇹
Instituto Europeo di Oncologia, Milan, Italy
🇬🇷
University General Hospital of Larissa, Larissa, Greece

and more 41 locations

A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: Elacestrant dihydrochloride

First Posted Date: 2023-11-13

Last Posted Date: 2024-11-19

Lead Sponsor: Stemline Therapeutics, Inc.

Target Recruit Count: 16

Registration Number: NCT06126575

Locations: 🇺🇸
Inland Empire Clinical Trials, LLC, Yucaipa, California, United States
🇺🇸
Floridian Clinical Research, Miami, Florida, United States
🇺🇸
American Research Corp, San Antonio, Texas, United States

DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment

Phase 2

Recruiting

Conditions: Ductal Carcinoma in Situ

Interventions: Drug: Testosterone + Anastrazole
Drug: Z-endoxifen
Drug: Tamoxifen
Drug: Elacestrant
Drug: Exemestane
Drug: Letrozole
Drug: Anastrazole

First Posted Date: 2023-10-10

Last Posted Date: 2025-04-29

Lead Sponsor: QuantumLeap Healthcare Collaborative

Target Recruit Count: 400

Registration Number: NCT06075953

Locations: 🇺🇸
Berkeley Outpatient Center, Berkeley, California, United States
🇺🇸
UCSF, San Francisco, California, United States
🇺🇸
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

and more 5 locations

Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer

Phase 2

Recruiting

Conditions: Premenopausal Breast Cancer
HER2-negative Breast Cancer
Breast Cancer
Hormone Receptor Positive Tumor

Interventions: Drug: Elacestrant
Drug: Triptorelin

First Posted Date: 2023-08-08

Last Posted Date: 2024-02-13

Lead Sponsor: SOLTI Breast Cancer Research Group

Target Recruit Count: 48

Registration Number: NCT05982093

Locations: 🇪🇸
Complejo Hospitalario de Navarra, Pamplona, Spain
🇪🇸
Hospital Universitari Vall d'Hebron, Barcelona, Spain
🇪🇸
Complejo Hospitalario San Pedro de Alcántara, Cáceres, Spain

and more 6 locations

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