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

Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001)

Phase 1

Terminated

Conditions: Cancer
Solid Tumors

Interventions: Drug: Vevorisertib
Drug: Fulvestrant
Drug: Paclitaxel

First Posted Date: 2016-05-04

Last Posted Date: 2023-05-06

Lead Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Target Recruit Count: 78

Registration Number: NCT02761694

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
🇺🇸
Mary Crowley Cancer Research, Dallas, Texas, United States

and more 3 locations

Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery

Phase 2

Recruiting

Conditions: Estrogen Receptor and/or Progesterone Receptor Positive
HER2/Neu Negative
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer

Interventions: Drug: Fulvestrant
Other: Laboratory Biomarker Analysis
Drug: Palbociclib
Other: Questionnaire Administration
Drug: Aromatase Inhibitors

First Posted Date: 2016-05-03

Last Posted Date: 2023-05-06

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Target Recruit Count: 37

Registration Number: NCT02760030

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
Case Western University, Cleveland, Ohio, United States
🇺🇸
St. Elizabeth Healthcare, Edgewood, Kentucky, United States

Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy

Phase 2

Completed

Conditions: Breast Neoplasms

Interventions: Drug: Fulvestrant
Drug: Sapanisertib

First Posted Date: 2016-04-29

Last Posted Date: 2023-02-08

Lead Sponsor: Calithera Biosciences, Inc

Target Recruit Count: 141

Registration Number: NCT02756364

Locations: 🇺🇸
New England Cancer Specialists, Scarborough, Maine, United States
🇺🇸
Texas Oncology, P.A., Dallas, Texas, United States
🇺🇸
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare, Fullerton, California, United States

and more 49 locations

Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor

Phase 2

Active, not recruiting

Conditions: Metastatic Breast Cancer

Interventions: Drug: Palbociclib
Drug: Fulvestrant

First Posted Date: 2016-04-14

Last Posted Date: 2024-12-13

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 60

Registration Number: NCT02738866

Locations: 🇺🇸
Reading Hospital - McGlinn Cancer Institute, West Reading, Pennsylvania, United States
🇺🇸
Kimmel Cancer Center at Johns Hopkins at Sibley Memorial Hospital, Washington, District of Columbia, United States
🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

and more 2 locations

Fulvestrant (F)+Placebo vs F+Palbociclib First Line for Postmenopausal Hormone Receptor+ Advanced Breast Cancer

Phase 2

Conditions: Breast Neoplasms

Interventions: Drug: PD-0332991 (Palbociclib)
Drug: Placebo
Drug: Fulvestrant

First Posted Date: 2016-02-24

Last Posted Date: 2020-02-05

Lead Sponsor: Spanish Breast Cancer Research Group

Target Recruit Count: 189

Registration Number: NCT02690480

Locations: 🇮🇪
Bon Secours Hospital, Cork, Ireland
🇮🇪
Galway University Hospital, Galway, Ireland
🇮🇪
Beaumont Hospital, Dublin, Ireland

and more 29 locations

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Gedatolisib
Drug: Palbociclib
Drug: Letrozole

First Posted Date: 2016-02-17

Last Posted Date: 2022-07-27

Lead Sponsor: Celcuity Inc

Target Recruit Count: 141

Registration Number: NCT02684032

Locations: 🇺🇸
The Emory Clinic, Atlanta, Georgia, United States
🇺🇸
Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Karmanos Cancer Institute, Farmington Hills, Michigan, United States

and more 33 locations

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

Phase 2

Completed

Conditions: HER-2 Positive Breast Cancer
Hormone Receptor Positive Breast Cancer

Interventions: Drug: Abemaciclib
Drug: Standard of Care Single Agent Chemotherapy
Drug: Trastuzumab
Drug: Fulvestrant

First Posted Date: 2016-02-05

Last Posted Date: 2024-11-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 237

Registration Number: NCT02675231

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Northwest Medical Specialties, PLLC, Puyallup, Washington, United States
🇺🇸
Comprehensive Blood and Cancer Center, Bakersfield, California, United States

and more 31 locations

An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Ribociclib
Drug: T-DM1
Drug: Trastuzumab
Drug: Fulvestrant

First Posted Date: 2016-01-15

Last Posted Date: 2022-08-01

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 25

Registration Number: NCT02657343

Locations: 🇺🇸
Massacusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase

Phase 1

Completed

Conditions: Solid Malignancies

Interventions: Drug: [14C]AZD2014
Drug: Multiple dose AZD2014
Drug: Fulvestrant
Drug: Paclitaxel

First Posted Date: 2015-12-29

Last Posted Date: 2019-04-22

Lead Sponsor: AstraZeneca

Target Recruit Count: 4

Registration Number: NCT02640755

Locations: 🇬🇧
Research Site, Manchester, United Kingdom

Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer

Phase 2

Completed

Conditions: Breast Carcinoma
Metastatic Breast Cancer

Interventions: Drug: LEE-011
Drug: Placebo
Drug: Fulvestrant

First Posted Date: 2015-12-16

Last Posted Date: 2024-12-06

Lead Sponsor: Melissa K Accordino

Target Recruit Count: 169

Registration Number: NCT02632045

Locations: 🇺🇸
Northside Hospital, Inc., Atlanta, Georgia, United States
🇺🇸
Northwestern Medical Hospital, Chicago, Illinois, United States
🇺🇸
The University of Kansas Cancer Center, Westwood, Kansas, United States

and more 10 locations

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