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

Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast

Not Applicable
Conditions
Breast Cancer
First Posted Date
2005-08-04
Last Posted Date
2013-11-06
Lead Sponsor
Cedars-Sinai Medical Center
Target Recruit Count
100
Registration Number
NCT00126464
Locations
🇺🇸

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, United States

Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
Interventions
First Posted Date
2005-01-07
Last Posted Date
2019-03-05
Lead Sponsor
Translational Oncology Research International
Target Recruit Count
108
Registration Number
NCT00100854
Locations
🇺🇸

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

Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

Phase 3
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2004-12-14
Last Posted Date
2025-01-15
Lead Sponsor
AstraZeneca
Target Recruit Count
736
Registration Number
NCT00099437
Locations
🇻🇪

Research Site, Caracas, Venezuela

Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2004-09-29
Last Posted Date
2008-06-12
Lead Sponsor
AstraZeneca
Target Recruit Count
179
Registration Number
NCT00093002
Locations
🇬🇧

Research Site, Edinburgh, United Kingdom

Tipifarnib and Fulvestrant in Hormone Receptor-Positive Metastatic Breast Cancer

Phase 2
Completed
Conditions
Estrogen Receptor-positive Breast Cancer
Recurrent Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Interventions
First Posted Date
2004-05-19
Last Posted Date
2018-11-01
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
33
Registration Number
NCT00082810
Locations
🇺🇸

Montefiore Medical Center, Bronx, New York, United States

S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2004-01-13
Last Posted Date
2021-01-13
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
695
Registration Number
NCT00075764
Locations
🇺🇸

Grant Medical Center Cancer Care, Columbus, Ohio, United States

🇺🇸

Mount Carmel Health - West Hospital, Columbus, Ohio, United States

🇺🇸

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States

and more 421 locations

The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer

Phase 3
Completed
Conditions
Metastatic Breast Cancer
Locally Advanced Breast Cancer
Interventions
First Posted Date
2003-07-23
Last Posted Date
2015-02-24
Lead Sponsor
AstraZeneca
Target Recruit Count
694
Registration Number
NCT00065325
Locations
🇬🇧

Research Site, Nottingham, United Kingdom

Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer

Phase 2
Completed
Conditions
Estrogen Receptor-positive Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage IV Breast Cancer
Recurrent Breast Cancer
Interventions
Other: laboratory biomarker analysis
First Posted Date
2003-04-09
Last Posted Date
2014-05-12
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
148
Registration Number
NCT00057941
Locations
🇺🇸

Eastern Cooperative Oncology Group, Boston, Massachusetts, United States

ICI 182780 in Treating Women With Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2003-01-27
Last Posted Date
2016-07-06
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
80
Registration Number
NCT00012025
Locations
🇨🇦

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

🇺🇸

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

🇺🇸

Siouxland Hematology-Oncology, Sioux City, Iowa, United States

and more 22 locations

ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer

Phase 3
Terminated
Conditions
Breast Cancer
First Posted Date
2003-01-27
Last Posted Date
2012-07-19
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Registration Number
NCT00010153
Locations
🇬🇧

Christie Hospital N.H.S. Trust, Manchester, England, United Kingdom

© Copyright 2025. All Rights Reserved by MedPath