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

Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer

Phase 2

Terminated

Conditions: Non-small Cell Lung Cancer
Postmenopausal Women

Interventions: Drug: fulvestrant (Faslodex)
Drug: Best supportive care
Drug: Bevacizumab (Avastin)
Drug: anastrozole (Arimidex)

First Posted Date: 2009-07-03

Last Posted Date: 2017-10-19

Lead Sponsor: University of Pittsburgh

Target Recruit Count: 3

Registration Number: NCT00932152

Locations: 🇺🇸
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

A Study, Comparing a Dose-Titration Regimen of Fulvestrant With the Approved Dosing Regimen in Postmenopausal Patients With Hormone-Responsive Advanced Breast Cancer (ABC)

Phase 2

Conditions: Breast Cancer

Interventions: Drug: Fulvestrant

First Posted Date: 2009-06-25

Last Posted Date: 2011-07-22

Lead Sponsor: Regina Elena Cancer Institute

Target Recruit Count: 104

Registration Number: NCT00927511

Locations: 🇮🇹
Regina Elena Cancer Institute, Rome, RM, Italy

Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer.

Phase 2

Completed

Conditions: Invasive Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Anastrazole

First Posted Date: 2009-06-16

Last Posted Date: 2023-05-19

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 42

Registration Number: NCT00921115

Locations: 🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States

Trial of Fulvestrant, MK-0646, and Dasatinib for Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer

Phase 1

Terminated

Conditions: Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Dasatinib
Drug: MK-0646

First Posted Date: 2009-05-15

Last Posted Date: 2015-02-02

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 11

Registration Number: NCT00903006

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: anastrozole
Drug: fulvestrant

First Posted Date: 2009-03-30

Last Posted Date: 2021-02-24

Lead Sponsor: Institut Bergonié

Target Recruit Count: 120

Registration Number: NCT00871858

Locations: 🇫🇷
Institut Bergonie, Bordeaux, France

Trial to Evaluate the Therapeutic Benefit of Fulvestrant in Combination With ZACTIMA in Postmenopausal Women With Bone Predominant, Hormone Receptor Positive Metastatic Breast Cancer

Phase 2

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Fulvestrant + ZACTIMA
Drug: Fulvestrant + Placebo

First Posted Date: 2008-12-19

Last Posted Date: 2013-11-18

Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

Target Recruit Count: 126

Registration Number: NCT00811369

Locations: 🇨🇦
British Columbia Cancer Agency - Vancouver Centre, Vancouver, British Columbia, Canada
🇨🇦
Grand River Regional Cancer Centre, Kitchener, Ontario, Canada
🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada

and more 10 locations

Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer

Phase 2

Terminated

Conditions: Breast Neoplasms

Interventions: Drug: AVE1642
Drug: Fulvestrant

First Posted Date: 2008-10-17

Last Posted Date: 2011-03-03

Lead Sponsor: Sanofi

Target Recruit Count: 18

Registration Number: NCT00774878

Locations: 🇪🇸
Sanofi-Aventis Administrative Office, Barcelona, Spain

Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor

Phase 2

Completed

Conditions: Advanced Breast Cancer

Interventions: Drug: Dasatinib
Drug: Fulvestrant

First Posted Date: 2008-09-17

Last Posted Date: 2016-05-26

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 100

Registration Number: NCT00754325

Locations: 🇺🇸
Kansas City Cancer Center, Llc., Overland Park, Kansas, United States
🇺🇸
Northern Arizona Hematology & Oncology Associates, Sedona, Arizona, United States
🇺🇸
Us Oncology Research, Inc., Houston, Texas, United States

and more 23 locations

ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: ZD6474 (Vandetanib at the dose of 100 mg)
Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)
Drug: Fulvestrant
Drug: ZD6474 (Vandetanib at the dose of 300 mg)
Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)