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
Associated Therapies
-

Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor

Phase 3
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2020-12-02
Last Posted Date
2024-07-31
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
250
Registration Number
NCT04650581
Locations
🇨🇦

QEII Health Sciences Centre, Halifax, Nova Scotia, Canada

🇨🇦

Centre Integre de Sante et de Services Sociaux, Greenfield Park, Quebec, Canada

🇨🇦

CHUM-Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada

and more 36 locations

Study of PF-07248144 in Advanced or Metastatic Solid Tumors

Phase 1
Recruiting
Conditions
Locally Advanced or Metastatic Non-small Cell Lung Cancer
Locally Advanced or Metastatic Castration-resistant Prostate Cancer
Locally Advanced or Metastatic ER+ HER2- Breast Cancer
Interventions
Drug: PF-07248144
Drug: Fulvestrant
Drug: Letrozole
Drug: PF-07220060
Drug: Palbociclib
First Posted Date
2020-10-28
Last Posted Date
2024-04-03
Lead Sponsor
Pfizer
Target Recruit Count
186
Registration Number
NCT04606446
Locations
🇺🇸

Thomas Jefferson University, Gibbon Building, Philadelphia, Pennsylvania, United States

🇺🇸

Thomas Jefferson University, Investigational Drug Service, Philadelphia, Pennsylvania, United States

🇺🇸

Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization, Philadelphia, Pennsylvania, United States

and more 51 locations

ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL

Phase 2
Active, not recruiting
Conditions
Breast Cancer Metastatic
Interventions
First Posted Date
2020-10-26
Last Posted Date
2024-07-05
Lead Sponsor
MedSIR
Target Recruit Count
162
Registration Number
NCT04603183
Locations
🇪🇸

Hospital Clinico Universitario de Valencia, Valencia, Spain

🇮🇹

Instituto Europeo di Oncologia, Milano, Italy

🇮🇹

Azienda Ospedaliero-Universitaria Cittá de la Salute e della Scienza, Torino, Italy

and more 28 locations

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Phase 2
Active, not recruiting
Conditions
Biliary Tract Neoplasms
Uterine Neoplasms
Urologic Neoplasms
Carcinoma, Non-Small-Cell Lung
HER2 Mutations Breast Neoplasms
Uterine Cervical Neoplasms
Interventions
First Posted Date
2020-10-08
Last Posted Date
2024-11-13
Lead Sponsor
Seagen Inc.
Target Recruit Count
217
Registration Number
NCT04579380
Locations
🇺🇸

HealthPartners Institute, Saint Louis Park, Minnesota, United States

🇺🇸

Texas Oncology, P.A. - Dallas, Dallas, Texas, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 63 locations

A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer

Phase 1
Active, not recruiting
Conditions
Breast Neoplasms
Interventions
First Posted Date
2020-10-01
Last Posted Date
2024-12-03
Lead Sponsor
Eisai Co., Ltd.
Target Recruit Count
72
Registration Number
NCT04572295
Locations
🇯🇵

Eisai Trial Site 10, Kitaadachi-gun, Saitama, Japan

🇯🇵

Eisai Trial Site 2, Shinagawa-ku, Tokyo, Japan

🇯🇵

Eisai Trial Site 6, Kashiwa, Chiba, Japan

and more 8 locations

DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer

Phase 2
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2020-09-28
Last Posted Date
2023-03-21
Lead Sponsor
Criterium, Inc.
Target Recruit Count
100
Registration Number
NCT04567420
Locations
🇺🇸

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

University of Arizona Cancer Center, Tucson, Arizona, United States

🇺🇸

University of Wisconsin Clinical Science Center, Madison, Wisconsin, United States

and more 12 locations

A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

First Posted Date
2020-09-21
Last Posted Date
2024-11-25
Lead Sponsor
AstraZeneca
Target Recruit Count
138
Registration Number
NCT04556773
Locations
🇨🇳

Research Site, Taoyuan, Taiwan

Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer

Phase 2
Active, not recruiting
Conditions
Breast Neoplasms
Interventions
First Posted Date
2020-09-10
Last Posted Date
2025-01-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
69
Registration Number
NCT04544189
Locations
🇨🇳

Novartis Investigative Site, Tianjin, China

Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy

Completed
Conditions
Neoplasm Malignant
Female
Breast
Interventions
First Posted Date
2020-08-24
Last Posted Date
2020-08-24
Lead Sponsor
Istituti Clinici Scientifici Maugeri SpA
Target Recruit Count
191
Registration Number
NCT04524728
Locations
🇮🇹

Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy

Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer

Phase 2
Active, not recruiting
Conditions
Advanced Breast Cancer
Interventions
First Posted Date
2020-08-24
Last Posted Date
2024-11-14
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT04524000
Locations
🇯🇵

Novartis Investigative Site, Niigata, Japan

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