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

Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Phase 1
Recruiting
Conditions
Advanced HR+/HER2- Breast Cancer
Advanced CCNE1-amplified Solid Tumors
Interventions
First Posted Date
2024-12-10
Last Posted Date
2025-05-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
280
Registration Number
NCT06726148
Locations
🇸🇬

Novartis Investigative Site, Singapore, Singapore

A Study of SIM0270 Combined with Everolimus Vs. Treatment of Physician's Choice in Patients with ER+/HER2- Advanced Breast Cancer (SIMRISE)

Phase 3
Recruiting
Conditions
Locally Advanced or Metastatic Breast Cancer
Interventions
First Posted Date
2024-11-08
Last Posted Date
2024-12-04
Lead Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Target Recruit Count
460
Registration Number
NCT06680921
Locations
🇨🇳

Harbin Medical University Cancer Hospital, Haerbin, Heilongjiang, China

🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors

Phase 1
Recruiting
Conditions
Metastatic Pancreatic Neuroendocrine Tumor
Interventions
First Posted Date
2024-10-29
Last Posted Date
2024-12-27
Lead Sponsor
University of Chicago
Target Recruit Count
25
Registration Number
NCT06663072
Locations
🇺🇸

University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients

Phase 3
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2024-10-10
Last Posted Date
2025-05-14
Lead Sponsor
AstraZeneca
Target Recruit Count
560
Registration Number
NCT06635447
Locations
🇨🇳

Research Site, Zhengzhou, China

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients with Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

Phase 2
Not yet recruiting
Conditions
Advanced Breast Carcinoma
Advanced Malignant Solid Neoplasm
Advanced Ovarian Carcinoma
Advanced Pancreatic Carcinoma
Advanced Prostate Carcinoma
Advanced Sarcoma
Anatomic Stage III Breast Cancer AJCC V8
Anatomic Stage IV Breast Cancer AJCC V8
Stage III Ovarian Cancer AJCC V8
Stage III Pancreatic Cancer AJCC V8
Interventions
First Posted Date
2024-10-08
Last Posted Date
2025-02-13
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
30
Registration Number
NCT06630325
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer

Phase 2
Recruiting
Conditions
CCCA Assessed by Ki67 Drop Below <2.7% From Baseline
Interventions
First Posted Date
2024-09-23
Last Posted Date
2025-04-02
Lead Sponsor
GBG Forschungs GmbH
Target Recruit Count
120
Registration Number
NCT06607757
Locations
🇩🇪

Hämato-Onkologie im Medicum - Onkologie und Hämatologie, Bremen, Germany

🇩🇪

Carl-Thiem-Klinikum gGmbH - Frauenklinik, Cottbus, Germany

🇩🇪

Kath. St. Paulus GmbH - Klinische Forschung, Dortmund, Germany

and more 22 locations

Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping

Phase 2
Not yet recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2024-08-19
Last Posted Date
2024-08-19
Lead Sponsor
Fudan University
Target Recruit Count
260
Registration Number
NCT06561022
Locations
🇨🇳

270 Dongan Road, Fudan University Shanghai Cancer Center, Shanghai, China

Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)

Completed
Conditions
Advanced Breast Cancer
Luminal Breast Cancer
Metastatic Breast Cancer
HER2-negative Breast Cancer
ER-positive Breast Cancer
Interventions
First Posted Date
2024-07-29
Last Posted Date
2024-12-13
Lead Sponsor
MedSIR
Target Recruit Count
419
Registration Number
NCT06525675
Locations
🇫🇷

Hopital Tenon, Paris, France

🇫🇷

Hospital Europeo Georges Pompidou AP-HP, Paris, France

🇫🇷

Institut Curie, Paris, France

and more 33 locations

Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced And/or Metastatic Breast Cancer

Phase 1
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2024-07-23
Last Posted Date
2025-01-07
Lead Sponsor
Biotheryx, Inc.
Target Recruit Count
82
Registration Number
NCT06515470
Locations
🇺🇸

Biotheryx Investigative Site, Fairfax, Virginia, United States

Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.

Phase 2
Conditions
Advanced/Metastatic Cancer
Interventions
First Posted Date
2024-07-18
Last Posted Date
2025-01-07
Lead Sponsor
Taiho Oncology, Inc.
Target Recruit Count
15
Registration Number
NCT06506955
Locations
🇫🇷

Institut Paoli-Calmettes, Marseille, France

🇰🇷

Severance Hospital, Seoul, Korea, Republic of

🇪🇸

Hospital Universitari, Vall d'Hebron, Barcelona, Spain

and more 5 locations
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