fulvestrant (Faslodex)

Other Medications · Approved since 2002

US Off-label EU EMA Approved ES Funded by SNS off-label in CRC Intramuscular 26 Clinical Trials
Estrogen receptor alpha

Description

Fulvestrant is a selective estrogen receptor degrader (SERD) that is FDA-approved for estrogen receptor-positive breast cancer but is being explored in colorectal cancer patients with HER2 alterations. In CRC, fulvestrant appears in clinical trials as combination therapy alongside HER2-targeted agents like tucatinib and trastuzumab for tumors harboring HER2 mutations or amplifications. This represents an off-label application exploring potential hormone pathway interactions in HER2-positive colorectal tumors.

Mechanism of Action

Fulvestrant binds to estrogen receptors with high affinity and promotes their degradation, effectively eliminating estrogen receptor signaling. Unlike selective estrogen receptor modulators, fulvestrant acts as a pure antagonist with no agonist activity, leading to complete blockade of estrogen-mediated cellular proliferation.

Molecular Targets

Side Effects

Injection site reactions Hot flashes Nausea Fatigue Headache Back pain Vomiting Constipation

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT07540572 Phase 1
Recruiting
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
United States
NCT07287917 Phase 1
Recruiting
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
United States
NCT07288359 Phase 1
Recruiting
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
United States, Denmark, Germany, Italy, Japan, Singapore, Spain, Taiwan
NCT07318805 Phase 1
Recruiting
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
United States
NCT07109726 Phase 1
Recruiting
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
United States, Puerto Rico
NCT06998407 Phase 1
Recruiting
ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors
United States
View all 26 clinical trials →

Quick Info

Brand NameFaslodex
CategoryOther Medications
US StatusOff-label
EU EMA StatusEMA Approved
ES Spain AccessFunded by SNS off-label in CRC
AdministrationIntramuscular
Year Approved2002
Clinical Trials26
View Clinical Trials Back to Drug Glossary

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Medical Disclaimer

This information is for educational purposes only and should not replace professional medical advice. Always consult your healthcare team before making treatment decisions.