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

Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer

Phase 1

Completed

Conditions: Advanced and Metastatic Breast Cancer

Interventions: Drug: AZD2014
Drug: Palbociclib
Drug: Fulvestrant

First Posted Date: 2015-11-09

Last Posted Date: 2024-06-06

Lead Sponsor: AstraZeneca

Target Recruit Count: 54

Registration Number: NCT02599714

Locations: 🇬🇧
Research Site, London, United Kingdom

A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: Fulvestrant
Drug: GDC-0810

First Posted Date: 2015-10-07

Last Posted Date: 2021-04-23

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 71

Registration Number: NCT02569801

Locations: 🇺🇸
Florida Cancer Specialists-Broadway, Fort Myers, Fort Myers, Florida, United States
🇺🇸
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building), Saint Petersburg, Florida, United States
🇺🇸
The Center for Cancer and Blood Disorders - Fort Worth, Fort Worth, Texas, United States

and more 41 locations

To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Palbociclib
Drug: Anastrozole
Drug: Letrozole
Drug: Exemestane
Drug: Fulvestrant

First Posted Date: 2015-09-15

Last Posted Date: 2017-08-01

Lead Sponsor: Fondazione Sandro Pitigliani

Target Recruit Count: 115

Registration Number: NCT02549430

Locations: 🇮🇹
Azienda Ospedaliera Papa Giovanni Xxiii, Bergamo, Italy
🇮🇹
Istituto Europeo Oncologia, Milano, Italy
🇮🇹
Ospedale Antonio Perrino, Brindisi, Italy

and more 3 locations

A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant

Phase 2

Terminated

Conditions: Female Breast Carcinoma
Female Ductal Carcinoma In Situ

Interventions: Drug: Fulvestrant

First Posted Date: 2015-09-03

Last Posted Date: 2024-04-03

Lead Sponsor: Atossa Therapeutics, Inc.

Target Recruit Count: 3

Registration Number: NCT02540330

Locations: 🇺🇸
Columbia University Medical Center, New York, New York, United States
🇺🇸
The Johns Hopkins School of Medicine, Baltimore, Maryland, United States
🇺🇸
Montefiore Medical Center, Bronx, New York, United States

Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer

Phase 2

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Palbociclib
Drug: Fulvestrant

First Posted Date: 2015-09-01

Last Posted Date: 2024-02-26

Lead Sponsor: ETOP IBCSG Partners Foundation

Target Recruit Count: 124

Registration Number: NCT02536742

Locations: 🇧🇪
CHU Liege, Liège, Belgium
🇧🇪
Cliniques Universitaires Saint-Luc, Brussels, Belgium
🇮🇹
Azienda USL4 Prato, Prato, Italy

and more 16 locations

Fulvestrant +/- Vandetanib in Advanced Aromatase Inhibitor Resistant Breast Cancer

Phase 2

Conditions: Neoplasms

Interventions: Drug: Fulvestrant
Drug: Vandetanib

First Posted Date: 2015-08-21

Last Posted Date: 2015-08-21

Lead Sponsor: Velindre NHS Trust

Target Recruit Count: 160

Registration Number: NCT02530411

Locations: 🇬🇧
Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom
🇬🇧
Velindre Cancer Center, Velindre Hospital, Cardiff, Wales, United Kingdom
🇬🇧
Royal United Hospital Bath, Bath, United Kingdom

and more 2 locations

"Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment "

Phase 2

Completed

Conditions: Breast Neoplasms

Interventions: Drug: Trastuzumab
Drug: Pertuzumab
Drug: Palbociclib
Drug: Fulvestrant

First Posted Date: 2015-08-21

Last Posted Date: 2020-07-15

Lead Sponsor: Fondazione Michelangelo

Target Recruit Count: 102

Registration Number: NCT02530424

Locations: 🇮🇹
Istituto Europeo di Oncologia, Milano, MI, Italy
🇮🇹
Policlinico Sant'Orsola Malpighi, Bologna, BO, Italy
🇮🇹
Azienda Ospedaliero Universitaria di Ferrara - Arcispedale S. Anna, Ferrara, FE, Italy

and more 4 locations