MedPath

Fulvestrant

Generic Name
Fulvestrant
Brand Names
Faslodex, Fulvestrant Mylan
Drug Type
Small Molecule
Chemical Formula
C32H47F5O3S
CAS Number
129453-61-8
Unique Ingredient Identifier
22X328QOC4
Background

Fulvestrant is a drug treatment of hormone receptor (HR)-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor. While it is used as monotherapy for the treatment of breast cancers, it is also used in combination with alpelisib for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer

Indication

For the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following anti-estrogen therapy, as monotherapy or in combination with other antineoplastic agents.

Associated Conditions
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Phase 1
Completed
Conditions
HER2-negative Breast Cancer
Breast Cancer
Unresectable Solid Tumor
PIK3CA Mutation
Solid Tumor, Adult
Hormone Receptor Positive Tumor
Metastatic Breast Cancer
Advanced Breast Cancer
Interventions
First Posted Date
2023-03-08
Last Posted Date
2025-05-16
Lead Sponsor
Relay Therapeutics, Inc.
Target Recruit Count
41
Registration Number
NCT05759949
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Community Cancer Center North, Indianapolis, Indiana, United States

🇺🇸

Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States

and more 4 locations

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

Phase 1
Recruiting
Conditions
Breast Cancer
Breast Cancer Metastatic
Hormone Receptor Positive Tumor
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Ovarian Cancer
Advanced Cancer
CCNE1 Amplification
Solid Tumor
Metastatic Cancer
Interventions
First Posted Date
2023-02-21
Last Posted Date
2025-04-27
Lead Sponsor
Incyclix Bio
Target Recruit Count
150
Registration Number
NCT05735080
Locations
🇺🇸

Georgia Cancer Center at Augusta University, Augusta, Georgia, United States

🇺🇸

Karmanos Cancer Institute, Detroit, Michigan, United States

🇺🇸

UTSW Medical Center, Dallas, Texas, United States

and more 7 locations

Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC

Phase 2
Recruiting
Conditions
Metastatic Breast Cancer
Premenopausal Breast Cancer
ER Positive Breast Cancer
Interventions
First Posted Date
2023-02-09
Last Posted Date
2024-06-10
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
42
Registration Number
NCT05720260
Locations
🇨🇳

Department of Oncology, National Taiwan University Hospital, Taipei City, Taiwan

Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

First Posted Date
2023-01-25
Last Posted Date
2025-05-15
Lead Sponsor
Sermonix Pharmaceuticals Inc.
Target Recruit Count
500
Registration Number
NCT05696626
Locations
🇨🇳

The First Hospital of Lanzhou University, Lanzhou, China

🇨🇳

Linyi Cancer Hospital, Linyi, China

🇨🇳

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China

and more 173 locations

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer

Phase 3
Active, not recruiting
Conditions
Advanced Breast Cancer
Interventions
First Posted Date
2022-12-16
Last Posted Date
2025-03-13
Lead Sponsor
Pfizer
Target Recruit Count
624
Registration Number
NCT05654623
Locations
🇺🇸

Morton Plant Hospital - BayCare Health System, Clearwater, Florida, United States

🇺🇸

3T Radiology LLC, Coconut Creek, Florida, United States

🇺🇸

Florida Cancer Specialists - South, Fort Myers, Florida, United States

and more 395 locations

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

Phase 3
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2022-12-12
Last Posted Date
2025-04-29
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
400
Registration Number
NCT05646862
Locations
🇦🇷

Clinica Viedma S.A., Viedma, Argentina

🇨🇳

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou City, China

🇨🇳

Sir Run Run Shaw Hospital Zhejiang University, Hangzhou City, China

and more 180 locations

Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment

Phase 4
Recruiting
Conditions
Advanced Breast Cancer
Interventions
First Posted Date
2022-11-30
Last Posted Date
2024-10-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
100
Registration Number
NCT05631795
Locations
🇮🇳

Novartis Investigative Site, New Delhi, India

VS-6766+Abema+Fulv in Met HR+/HER- BC

Phase 1
Recruiting
Conditions
Breast Cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer
Hormone Receptor-positive Breast Cancer
Interventions
First Posted Date
2022-11-08
Last Posted Date
2025-02-28
Lead Sponsor
Adrienne G. Waks
Target Recruit Count
63
Registration Number
NCT05608252
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institite, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer

Phase 2
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2022-11-01
Last Posted Date
2025-01-14
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
484
Registration Number
NCT05601440
Locations
🇨🇦

Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

🇨🇦

Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

🇨🇦

Odette Cancer Centre, Toronto, Ontario, Canada

and more 7 locations

SNF Platform Study of HR+/ HER2-advanced Breast Cancer

Phase 2
Recruiting
Conditions
HER2-negative Breast Cancer
Advanced Breast Cancer
Breast Neoplasm
Breast Cancer
Hormone Receptor Positive Tumor
Interventions
First Posted Date
2022-10-26
Last Posted Date
2024-10-04
Lead Sponsor
Fudan University
Target Recruit Count
620
Registration Number
NCT05594095
Locations
🇨🇳

Breast cancer institute of Fudan University Cancer Hospital, Shanghai, Shanghai, China

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