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

Associated Therapies: -

Clinical Trials

A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

Phase 2

Terminated

Conditions: Estrogen Receptor-positive (ER+)/Human Epidermal Growth Factor Receptor (HER2)-Negative Locally Advanced or Metastatic Breast Cancer

Interventions: Drug: Venetoclax
Drug: Fulvestrant

First Posted Date: 2018-07-12

Last Posted Date: 2022-06-28

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 103

Registration Number: NCT03584009

Locations: 🇺🇸
University of Maryland Medical Center, Baltimore, Maryland, United States
🇺🇸
Nebraska Hematology Onco, PC, Lincoln, Nebraska, United States
🇦🇺
Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research, North Sydney, New South Wales, Australia

and more 37 locations

Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer Metastatic

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

First Posted Date: 2018-06-14

Last Posted Date: 2023-07-07

Lead Sponsor: German Breast Group

Target Recruit Count: 56

Registration Number: NCT03555877

Locations: 🇩🇪
Studienzentrum Onkologie Ravensburg, Ravensburg, Germany

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

First Posted Date: 2018-06-12

Last Posted Date: 2023-05-15

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 20

Registration Number: NCT03554044

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

Phase 2

Active, not recruiting

Conditions: Malignant Neoplasms of Female Genital Organs

Interventions: Drug: Fulvestrant
Drug: Abemaciclib

First Posted Date: 2018-05-22

Last Posted Date: 2024-08-19

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 18

Registration Number: NCT03531645

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

Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Ribociclib
Drug: Alpelisib
Drug: Fulvestrant
Drug: Letrozole

First Posted Date: 2018-02-20

Last Posted Date: 2024-08-01

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 287

Registration Number: NCT03439046

Locations: 🇮🇹
Novartis Investigative Site, Napoli, Italy

Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer

Phase 3

Active, not recruiting

Conditions: Breast Neoplasm Female

Interventions: Drug: CDK 4/6 inhibitor
Drug: Non-Steroidal Aromatase Inhibitor
Drug: Fulvestrant

First Posted Date: 2018-02-08

Last Posted Date: 2023-08-18

Lead Sponsor: Borstkanker Onderzoek Groep

Target Recruit Count: 1050

Registration Number: NCT03425838

Locations: 🇳🇱
VUmc, Amsterdam, Netherlands
🇳🇱
OLVG, Amsterdam, Netherlands
🇳🇱
Gelre ziekenhuizen, Apeldoorn, Netherlands

and more 69 locations

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

First Posted Date: 2018-02-06

Last Posted Date: 2024-12-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 580

Registration Number: NCT03424005

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
University of California San Diego Medical Center; Moores Cancer Center, La Jolla, California, United States
🇺🇸
Stanford Cancer Institute, Stanford, California, United States

and more 36 locations

Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Fulvestrant

First Posted Date: 2018-01-09

Last Posted Date: 2023-07-05

Lead Sponsor: Nancy Chan, MD

Target Recruit Count: 47

Registration Number: NCT03393845

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Michigan State University, Breslin Cancer Center, Lansing, Michigan, United States
🇺🇸
New York University Clinical Cancer Center, New York, New York, United States

and more 2 locations

Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer

Phase 2

Withdrawn

Conditions: Estrogen Receptor Positive
HER2/Neu Negative
Progesterone Receptor Positive
Stage IV Breast Cancer AJCC v6 and v7

Interventions: Drug: Fulvestrant
Drug: Copanlisib
Other: Laboratory Biomarker Analysis
Drug: Palbociclib

First Posted Date: 2017-12-19

Last Posted Date: 2018-08-14

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT03377101

Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies

Phase 1

Completed

Conditions: Advanced Solid Malignancies

Interventions: Drug: CT7001
Drug: Fulvestrant

First Posted Date: 2017-12-06

Last Posted Date: 2023-12-22

Lead Sponsor: Carrick Therapeutics Limited

Target Recruit Count: 124

Registration Number: NCT03363893

Locations: 🇺🇸
Research Site 34, Boston, Massachusetts, United States
🇺🇸
Research Site 38, Chicago, Illinois, United States
🇬🇧
Research Site 6, Southampton, United Kingdom

and more 20 locations

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