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 abili...

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
Associated Therapies
-

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

First Posted Date
2024-11-15
Last Posted Date
2024-11-21
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
Interventions
First Posted Date
2024-10-15
Last Posted Date
2024-11-26
Lead Sponsor
Stemline Therapeutics, Inc.
Target Recruit Count
124
Registration Number
NCT06638307
Locations
🇺🇸

Highlands Oncology Group, Springdale, Arkansas, United States

🇺🇸

UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Yale Comprehensive Cancer Center, New Haven, Connecticut, United States

and more 26 locations

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

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

First Posted Date
2024-07-09
Last Posted Date
2024-12-04
Lead Sponsor
Stemline Therapeutics, Inc.
Target Recruit Count
4220
Registration Number
NCT06492616
Locations
🇺🇸

Cancer Centers of Kansas, Wichita, Kansas, United States

🇺🇸

Miami Valley Hospital South, Centerville, Ohio, United States

🇺🇸

Virginia Cancer Institute, Mechanicsville, Virginia, United States

and more 1 locations

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

First Posted Date
2024-04-24
Last Posted Date
2024-12-20
Lead Sponsor
MedSIR
Target Recruit Count
240
Registration Number
NCT06382948
Locations
🇪🇸

Hospital Universitario Doce de Octubre, Madrid, Spain

🇪🇸

Hospital Arnau de Vilanova de Valencia, Valencia, Spain

🇬🇧

Barts Health NHS Trust, London, United Kingdom

and more 1 locations

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

First Posted Date
2023-10-10
Last Posted Date
2024-10-08
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

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

Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2022-11-16
Last Posted Date
2023-03-28
Lead Sponsor
Context Therapeutics Inc.
Target Recruit Count
67
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

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2022-10-27
Last Posted Date
2024-12-05
Lead Sponsor
Stemline Therapeutics, Inc.
Target Recruit Count
80
Registration Number
NCT05596409
Locations
🇲🇽

Fucam, Ac., Ciudad de Mexico, Mexico

🇺🇸

Highlands Oncology Group, PA, Springdale, Arkansas, United States

🇺🇸

OPN Healthcare, Arcadia, California, United States

and more 27 locations

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

First Posted Date
2022-10-03
Last Posted Date
2024-11-18
Lead Sponsor
Stemline Therapeutics, Inc.
Target Recruit Count
400
Registration Number
NCT05563220
Locations
🇩🇪

Universitaetsklinikum Mannheim, Mannheim, Baden-Wuerttemberg, Germany

🇺🇸

Dothan Hematology and Oncology, Dothan, Alabama, United States

🇺🇸

Mayo Clinic - Arizona, Phoenix, Arizona, United States

and more 108 locations
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