This study is looking at whether adding neratinib, an FDA-approved medicine, can help control metastatic breast cancer that is estrogen receptor-positive (ER+) and HER2-negative (HER2-), and has become resistant to standard hormone therapy. Neratinib is currently used for HER2-positive breast cancers. You might be able to join if you are a woman over 18 with this type of breast cancer that has progressed after initial treatment, and you have at least one visible tumor. Researchers will also be looking at the safety of adding neratinib to standard treatments like letrozole, anastrozole, exemestane, tamoxifen, or fulvestrant, with or without CDK4/6 inhibitors. The study aims to enroll 150 participants and will measure how long people live without their cancer getting worse, and what side effects they experience.

Study design

This is a Phase II study that will enroll 150 participants. You would be randomly assigned to receive either standard care alone or standard care plus neratinib.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

Your progress and any side effects will be monitored from when you join until the study ends, which is expected to be about one year on average.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.