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

SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)

Phase 2
Recruiting
Conditions
Congenital, Familial and Genetic Disorders
Neoplasm, Breast
Interventions
First Posted Date
2022-05-26
Last Posted Date
2023-10-06
Lead Sponsor
Borstkanker Onderzoek Groep
Target Recruit Count
130
Registration Number
NCT05392608
Locations
🇳🇱

Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands

🇳🇱

Noordwest Ziekenhuisgroep, Alkmaar, Netherlands

🇳🇱

Ziekenhuis Amstelland, Amstelveen, Netherlands

and more 22 locations

Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

Phase 1
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2022-05-20
Last Posted Date
2025-02-21
Lead Sponsor
Tvardi Therapeutics, Incorporated
Target Recruit Count
6
Registration Number
NCT05384119
Locations
🇺🇸

Holy Cross Health Fort Lauderdale - Holy Cross Hospital, Fort Lauderdale, Florida, United States

🇺🇸

Vanderbilt - Ingram Cancer Center, Nashville, Tennessee, United States

🇺🇸

Washington University School of Medicine Siteman Cancer Center, Saint Louis, Missouri, United States

and more 3 locations

To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer

Phase 3
Active, not recruiting
Conditions
HR-positive, HER2-negative Breast Neoplasms
Interventions
Drug: TQB3616 capsule
Drug: Placebo
First Posted Date
2022-05-09
Last Posted Date
2023-12-29
Lead Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Target Recruit Count
432
Registration Number
NCT05365178
Locations
🇨🇳

The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China

🇨🇳

Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China

🇨🇳

Gansu Provincial Cancer Hospital, Lanzhou, Gansu, China

and more 85 locations

Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02)

First Posted Date
2022-04-14
Last Posted Date
2023-09-25
Lead Sponsor
Henan Cancer Hospital
Target Recruit Count
120
Registration Number
NCT05328440
Locations
🇨🇳

Henan Cancer Hospital, Zhengzhou, Henan, China

Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer

Phase 1
Recruiting
Conditions
Metastatic HER2-Positive Breast Carcinoma
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Interventions
First Posted Date
2022-04-08
Last Posted Date
2025-05-13
Lead Sponsor
Jonsson Comprehensive Cancer Center
Target Recruit Count
18
Registration Number
NCT05319873
Locations
🇺🇸

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

Phase 1
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2022-04-01
Last Posted Date
2025-04-18
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
400
Registration Number
NCT05307705
Locations
🇫🇷

Gustave Roussy, Villejuif, France

🇩🇪

Universitätsklinikum Erlangen, Erlangen, Bayern, Germany

🇺🇸

Mayo Clinic of Scottsdale, Scottsdale, Arizona, United States

and more 51 locations

A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)

Phase 3
Active, not recruiting
Conditions
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
Interventions
First Posted Date
2022-04-01
Last Posted Date
2025-04-15
Lead Sponsor
Genentech, Inc.
Target Recruit Count
320
Registration Number
NCT05306340
Locations
🇯🇵

Nagoya University Hospital, Aichi, Japan

🇿🇦

Medical Oncology Centre of Rosebank, Johannesburg, South Africa

🇪🇸

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, La Coruña, LA Coruna, Spain

and more 175 locations

Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer

Phase 2
Recruiting
Conditions
ER-Positive Breast Cancer
HER2-negative Breast Cancer
Interventions
First Posted Date
2022-03-31
Last Posted Date
2025-04-02
Lead Sponsor
The Methodist Hospital Research Institute
Target Recruit Count
28
Registration Number
NCT05305924
Locations
🇺🇸

Houston Methodist Cancer Center, Houston, Texas, United States

A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors

Phase 1
Active, not recruiting
Conditions
Breast Cancer
Solid Tumors
Interventions
First Posted Date
2022-03-02
Last Posted Date
2024-11-18
Lead Sponsor
Pfizer
Target Recruit Count
240
Registration Number
NCT05262400
Locations
🇺🇸

Administrative Address: UCLA Hematology/Oncology, Los Angeles, California, United States

🇺🇸

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States

🇺🇸

UCLA Hematology/Oncology, Los Angeles, California, United States

and more 46 locations

(VELA) Study of BLU-222 in Advanced Solid Tumors

Phase 1
Active, not recruiting
Conditions
HR+ Breast Cancer
Carcinosarcoma
Advanced Solid Tumors
CCNE1 Amplification
HER2-negative Breast Cancer
Gastric Cancer
Esophageal Adenocarcinoma
Ovarian Cancer
Endometrial Cancer
Interventions
First Posted Date
2022-02-23
Last Posted Date
2025-01-17
Lead Sponsor
Blueprint Medicines Corporation
Target Recruit Count
366
Registration Number
NCT05252416
Locations
🇺🇸

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

🇺🇸

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

🇺🇸

Stanford Women's Cancer Center, Stanford, California, United States

and more 20 locations
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