Spots Global Cancer Trial Database for Fulvestrant + Neratinib In Breast Cancer

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Trial Identification

Brief Title: Fulvestrant + Neratinib In Breast Cancer

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

Study ID: NCT04901299

Conditions

Stage IV (Metastatic) Breast Cancer

Metastatic Breast Cancer

ER Positive Breast Cancer

PR-Positive Breast Cancer

HER2-negative Breast Cancer

Invasive Breast Cancer

Interventions

NERATINIB

FULVESTRANT

Study Description

Brief 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

Detailed 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.