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

An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective

Phase 2

Completed

Conditions: Solid Tumors

Interventions: Drug: dovitinib
Drug: fulvestrant

First Posted Date: 2014-04-17

Last Posted Date: 2018-03-01

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 12

Registration Number: NCT02116803

Locations: 🇪🇸
Novartis Investigative Site, Palma De Mallorca, Islas Baleares, Spain

Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer

Phase 2

Withdrawn

Conditions: Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Entinostat
Drug: Placebo

First Posted Date: 2014-04-16

Last Posted Date: 2014-10-08

Lead Sponsor: Syndax Pharmaceuticals

Registration Number: NCT02115594

Locations: 🇺🇸
Tennessee Oncololgy, Nashville, Tennessee, United States

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

Phase 3

Active, not recruiting

Conditions: Breast Neoplasms

Interventions: Drug: Abemaciclib
Drug: Fulvestrant
Drug: Placebo

First Posted Date: 2014-04-08

Last Posted Date: 2024-08-01

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 669

Registration Number: NCT02107703

Locations: 🇲🇽
OCA Hospital, Monterrey, Nuevo León, Mexico
🇺🇸
Kaiser Permanente, Riverside, California, United States
🇺🇸
University of California - San Diego, La Jolla, California, United States

and more 136 locations

Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: LEE011
Drug: fulvestrant
Drug: BYL719
Drug: BKM120

First Posted Date: 2014-03-17

Last Posted Date: 2020-12-17

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 70

Registration Number: NCT02088684

Locations: 🇺🇸
Sarah Cannon Research Institute Onc Dept, Nashville, Tennessee, United States
🇺🇸
University of Alabama at Birmingham/ Kirklin Clinic Dept Onc, Birmingham, Alabama, United States
🇺🇸
Dana Farber Cancer Institute Onc. Dept., Boston, Massachusetts, United States

and more 1 locations

The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer

Phase 2

Conditions: Metastatic Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Anastrozole
Drug: Goserelin

First Posted Date: 2014-02-26

Last Posted Date: 2014-02-26

Lead Sponsor: Hospital Affiliated to Military Medical Science, Beijing

Target Recruit Count: 180

Registration Number: NCT02072512

Locations: 🇨🇳
307 Hospital, Beijing, Beijing, China

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

Phase 1

Active, not recruiting

Conditions: Breast Neoplasms

Interventions: Drug: LY2835219
Drug: Trastuzumab
Drug: LY3023414
Drug: Endocrine therapy
Drug: Letrozole
Drug: Exemestane
Drug: Anastrozole
Drug: Tamoxifen
Drug: Fulvestrant
Drug: Everolimus
Drug: Pertuzumab
Drug: Loperamide

First Posted Date: 2014-02-06

Last Posted Date: 2024-08-28

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 198

Registration Number: NCT02057133

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Highlands Oncology Group - Duplicate 2, Rogers, Arkansas, United States
🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

and more 10 locations

Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Sapanisertib
Drug: Fulvestrant
Drug: Exemestane

First Posted Date: 2014-01-30

Last Posted Date: 2023-02-08

Lead Sponsor: Calithera Biosciences, Inc

Target Recruit Count: 118

Registration Number: NCT02049957

Locations: 🇺🇸
Henry Ford Medical Center, Novi, Michigan, United States
🇺🇸
Texas Oncology, P.A. - Tyler, Tyler, Texas, United States
🇫🇷
Institut Sainte Catherine, Avignon, Vaculuse, France

and more 37 locations

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

Phase 3

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Palbociclib
Drug: Capecitabine
Drug: Exemestane
Drug: Fulvestrant

First Posted Date: 2014-01-07

Last Posted Date: 2021-01-20

Lead Sponsor: Spanish Breast Cancer Research Group

Target Recruit Count: 693

Registration Number: NCT02028507

Locations: 🇮🇱
Sheba Medical Center, Tel Hashomer, Israel
🇦🇹
Universitätsklinik für Innere Medizin III, Salzburg, Austria
🇦🇹
Landes-Krankenhaus Steyr, Steyr, Austria

and more 34 locations