Fulvestrant

Generic Name: Fulvestrant

Brand Names: Faslodex, Fulvestrant Mylan

Drug Type: Small Molecule

Chemical Formula: C_₃₂H_₄₇F_₅O_₃S

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

Clinical Trials

Exploring Whether Disease-free Intervals Can Guide Endocrine Combined Targeted Therapy for ER+/HER2+ Advanced Breast Cancer (T-sunflower)

Phase 2

Not yet recruiting

Conditions: Metastatic Breast Cancer

Interventions: Drug: Trastuzumab
Drug: pyrotinib
Drug: Dalpiciclib
Drug: fulvestrant

First Posted Date: 2022-10-13

Last Posted Date: 2022-10-13

Lead Sponsor: Fudan University

Target Recruit Count: 126

Registration Number: NCT05577923

Locations: 🇨🇳
Fudan University Shanghai Cancer Center Shanghai, China, 200032, Shanghai, Shanghai, China

Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer

Phase 1

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Dalpiciclib
Drug: Fulvestrant
Drug: Pertuzumab
Drug: Trastuzumab

First Posted Date: 2022-10-12

Last Posted Date: 2024-02-26

Lead Sponsor: Fudan University

Target Recruit Count: 72

Registration Number: NCT05574881

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Phase 2

Recruiting

Conditions: Advanced Malignant Solid Neoplasm
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Locally Advanced Malignant Solid Neoplasm
Malignant Female Reproductive System Neoplasm
Metastatic HER2-Negative Breast Carcinoma
Metastatic Malignant Solid Neoplasm
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Malignant Female Reproductive System Neoplasm

Interventions: Drug: Alpelisib
Drug: Binimetinib
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Scan
Drug: Ipatasertib
Procedure: Computed Tomography
Procedure: Echocardiography Test
Drug: Nilotinib Hydrochloride Monohydrate
Biological: Panitumumab
Procedure: Magnetic Resonance Imaging
Drug: Palbociclib
Drug: Fluorouracil
Drug: Paclitaxel
Drug: Sotorasib
Drug: Olaparib
Drug: Leucovorin
Drug: Fulvestrant
Procedure: Mutation Carrier Screening
Drug: Neratinib Maleate
Procedure: Positron Emission Tomography
Procedure: Multigated Acquisition Scan
Drug: Selumetinib Sulfate
Drug: Oxaliplatin

First Posted Date: 2022-10-03

Last Posted Date: 2025-05-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2900

Registration Number: NCT05564377

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
🇺🇸
Alaska Women's Cancer Care, Anchorage, Alaska, United States

and more 443 locations

Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)

Phase 2

Terminated

Conditions: Anatomic Stage IV Breast Cancer AJCC v8
Metastatic HER2-Negative Breast Carcinoma
Metastatic Hormone Receptor-Positive Breast Carcinoma

Interventions: Drug: Binimetinib
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Echocardiography Test
Drug: Fulvestrant
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan

First Posted Date: 2022-09-26

Last Posted Date: 2025-04-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1

Registration Number: NCT05554354

Locations: 🇺🇸
VCU Community Memorial Health Center, South Hill, Virginia, United States
🇺🇸
Carle at The Riverfront, Danville, Illinois, United States
🇺🇸
UI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny, Iowa, United States

and more 193 locations

Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor

Phase 2

Recruiting

Conditions: Advanced Breast Cancer

Interventions: Drug: Olaparib
Drug: Fulvestrant

First Posted Date: 2022-09-10

Last Posted Date: 2025-04-17

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 64

Registration Number: NCT05536128

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer

Phase 2

Recruiting

Conditions: Metastatic Breast Cancer
Hormone Receptor-positive Breast Cancer
Breast Cancer
HER2-negative Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Anastrozole
Drug: Abemaciclib

First Posted Date: 2022-09-01

Last Posted Date: 2024-06-07

Lead Sponsor: University of California, Irvine

Target Recruit Count: 20

Registration Number: NCT05524584

Locations: 🇺🇸
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States

A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer

Phase 1

Recruiting

Conditions: Breast Cancer

Interventions: Drug: HS-10352 combined with fulvestrant (Stage 1)
Drug: HS-10352 combined with fulvestrant (Stage 2)

First Posted Date: 2022-08-17

Last Posted Date: 2022-08-17

Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Target Recruit Count: 224

Registration Number: NCT05504213

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Gedatolisib
Drug: Palbociclib
Drug: Alpelisib

First Posted Date: 2022-08-16

Last Posted Date: 2024-12-19

Lead Sponsor: Celcuity Inc

Target Recruit Count: 701

Registration Number: NCT05501886

Locations: 🇺🇸
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
🇺🇸
Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A., Winter Haven, Florida, United States
🇺🇸
John D. Archbold Memorial Hospital, Thomasville, Georgia, United States

and more 214 locations

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

Phase 2

Recruiting

Conditions: Locoregional Recurrence
Hormone Receptor-positive Breast Cancer
HER2-negative Breast Cancer

Interventions: Drug: Ribociclib
Drug: Fulvestrant
Drug: Anastrozole
Drug: Letrozole
Drug: Exemestane

First Posted Date: 2022-07-21

Last Posted Date: 2025-04-08

Lead Sponsor: Oana Danciu

Target Recruit Count: 200

Registration Number: NCT05467891

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
University of Arizona, Phoenix, Arizona, United States
🇺🇸
Orlando Health Cancer Institute, Orlando, Florida, United States

and more 15 locations

A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

Phase 3

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: BPI-16350
Drug: placebo
Drug: Fulvestrant

First Posted Date: 2022-06-27

Last Posted Date: 2023-07-27

Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Target Recruit Count: 274

Registration Number: NCT05433480

Locations: 🇨🇳
Affiliated Hospital of Chengde Medical University, Chengde, Hebei, China
🇨🇳
Sun Yat-Sen University Cancer Hospital, Guangzhou, Guangdong, China
🇨🇳
Inner Mongolia People's Hospital, Hohhot, Neimenggu, China

and more 61 locations

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