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

Clinical Trials

I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers

Phase 1

Not yet recruiting

Conditions: Breast Cancer

Interventions: Drug: M1774
Drug: Fulvestrant injection

First Posted Date: 2023-08-14

Last Posted Date: 2024-03-29

Lead Sponsor: Institut Paoli-Calmettes

Target Recruit Count: 57

Registration Number: NCT05986071

Locations: 🇫🇷
Institut Paoli Calmettes, Marseille, France

A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: Benralizumab
Drug: fulvestrant or AIs) and PI3K inhibition (alpelisib)

First Posted Date: 2023-07-28

Last Posted Date: 2024-08-29

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 1

Registration Number: NCT05966584

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities), Commack, New York, United States

and more 4 locations

A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants

Phase 2

Active, not recruiting

Conditions: Metastatic Breast Cancer
Locally Advanced Breast Cancer
Breast Cancer

Interventions: Drug: Samuraciclib
Drug: Fulvestrant

First Posted Date: 2023-07-27

Last Posted Date: 2025-02-21

Lead Sponsor: Carrick Therapeutics Limited

Target Recruit Count: 60

Registration Number: NCT05963984

Locations: 🇺🇸
Ocala Oncology Center PL DBA Florida Cancer Affiliates, Ocala, Florida, United States
🇺🇸
Mfsmc-Hjwci, Baltimore, Maryland, United States
🇺🇸
Saint Luke's Cancer Institute, Kansas City, Missouri, United States

and more 29 locations

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Phase 2

Recruiting

Conditions: Advanced Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Neratinib
Drug: Alpelisib
Drug: Everolimus
Drug: Abemaciclib

First Posted Date: 2023-07-06

Last Posted Date: 2023-10-26

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 135

Registration Number: NCT05933395

Locations: 🇺🇸
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States

[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer

Phase 1

Recruiting

Conditions: Breast Cancer

Interventions: Drug: [68Ga]Ga-NeoB
Drug: [177Lu]Lu-NeoB
Drug: Ribociclib
Drug: Fulvestrant
Other: Goserelin

First Posted Date: 2023-05-23

Last Posted Date: 2025-05-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 48

Registration Number: NCT05870579

Locations: 🇺🇸
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

and more 2 locations

Study of AVZO-021 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumor
HR+/HER2- Breast Cancer
HR+, HER2-, Advanced Breast Cancer
CCNE1 Amplification
Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Endometrial Cancer
TNBC - Triple-Negative Breast Cancer

Interventions: Drug: AVZO-021
Drug: Palbociclib
Drug: Fulvestrant
Drug: Letrozole
Drug: Ribociclib
Drug: Abemaciclib
Drug: Carboplatin
Drug: Sacituzumab Govitecan-hziy

First Posted Date: 2023-05-19

Last Posted Date: 2025-04-03

Lead Sponsor: Avenzo Therapeutics, Inc.

Target Recruit Count: 430

Registration Number: NCT05867251

Locations: 🇺🇸
Texas Oncology - DFW, Dallas, Texas, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States

and more 6 locations

Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

Phase 2

Recruiting

Conditions: Metastatic Breast Cancer

Interventions: Drug: Fulvestrant plus AI plus ribociclib
Drug: AI plus ribociclib

First Posted Date: 2023-04-18

Last Posted Date: 2025-03-18

Lead Sponsor: Korea University Guro Hospital

Target Recruit Count: 202

Registration Number: NCT05816655

Locations: 🇰🇷
St Mary Hospital, Seoul, Korea, Republic of
🇰🇷
Korea university Guro hospital, Seoul, Korea, Republic of

Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy

Phase 2

Not yet recruiting

Conditions: Breast Cancer

Interventions: Drug: Dalpiciclib
Drug: Pyrotinib
Drug: Fulvestrant

First Posted Date: 2023-04-10

Last Posted Date: 2023-04-10

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Target Recruit Count: 30

Registration Number: NCT05806671

Locations: 🇨🇳
Tianjin Cancer Hospital, Tianjin, China

A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.

Phase 1

Not yet recruiting

Conditions: HER2 Low Advanced or Metastatic Breast Cancer

Interventions: Drug: SHR-A1811 & Bevacizumab injection
Drug: SHR-A1811 & Fulvestrant
Drug: SHR-A1811 & Dalpiciclib Isethionate Tablets

First Posted Date: 2023-03-31

Last Posted Date: 2023-03-31

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 300

Registration Number: NCT05792410

First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Breast Cancer
Gynecologic Cancer
HNSCC
Solid Tumors, Adult

Interventions: Drug: STX-478
Drug: Fulvestrant
Drug: Ribociclib
Drug: Palbociclib

First Posted Date: 2023-03-14

Last Posted Date: 2025-04-16

Lead Sponsor: Scorpion Therapeutics, Inc.

Target Recruit Count: 400

Registration Number: NCT05768139

Locations: 🇪🇸
START Barcelona_HM Nou Delfos, Barcelona, Spain
🇪🇸
Instituto de Investigacion Oncologica Vall d'Hebron, Barcelona, Spain
🇪🇸
Hospital Clínico San Carlos, Madrid, Spain

and more 30 locations

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