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.
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