Fulvestrant + Neratinib In Breast Cancer — HER2-Signal  

Metastatic Breast Cancer Clinical Trial

Official title: An Open-Label Phase II Trial of Fulvestrant And Neratinib in Previously Treated HRPositive, HER2-Negative Metastatic Breast Cancer Subjects Assessed With a Test Measuring Live Cell HER2 Signaling Function

Status Withdrawn

Clinical Trial Summary

This is a Phase 2 open label, multi-center non-randomized interventional study designed to evaluate the safety and efficacy of combining Neratinib plus Fulvestrant in previously treated metastatic HR-positive, HER2-negative breast cancer.

• This research study involves the study drug Neratinib

• The standard of care drug Fulvestrant

Clinical Trial Description

• The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

• This research study involves the study drug Neratinib

• The standard of care drug Fulvestrant

• It is expected that about 25 people will take part in this research study.

• This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

• The U.S. Food and Drug Administration (FDA) has not approved Neratinib for this specific disease but it has been approved for other uses.

• The FDA has approved Fulvestrant as a treatment option for this disease. Fulvestrant is a standard of care drug that will be administered. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• ER Positive Breast Cancer
• HER2-negative Breast Cancer
• Invasive Breast Cancer
• Metastatic Breast Cancer
• PR-Positive Breast Cancer
• Stage IV (Metastatic) Breast Cancer

• NCT number: NCT04901299
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2023
• Completion date: July 1, 2025