The goal of this clinical trial is to learn if neratinib, an FDA-approved oral pan-HER2/3/4 inhibitor, improves disease control for participants with metastatic endocrine-resistant ER+/HER2-negative breast cancer. Neratinib is already approved for the treatment of HER2-postive breast cancers. The study will also learn about the safety of adding this drug to standard of care treatments. The main questions it aims to answer are:
1. Does adding neratinib to standard of care systemic therapy improve disease control for patients with metastatic hormone-driven breast cancer that is resistant to endocrine therapy? 2. What side effects do participants have when adding neratinib to standard of care therapy? Researchers will compare standard of care endocrine therapy regimens with and without neratinib to see if neratinib improves control of treatment-resistant metastatic breast cancer that has continued to progress while eon first line endocrine therapy.
Participants will:
1. Take standard of care endocrine therapy for metastatic endocrine-resistant breast cancer as determined by their medical oncologist or standard of care therapy with neratinib daily 2. Visit the clinic every 3 months for checkups, tests and imaging studies
Female over the age of 18 at the time of study enrollment
Not pregnant, planning to become pregnant or breast feeding
Metastatic ER+/HER2- breast cancer that has progressed on 1st line therapy including endocrine therapy +/- CDK4/6 inhibitors
At least one metastatic lesion visible on imaging (including FDG-PET)
History of concurrent use of other HER2-targeted therapy
Concurrent use of other targeted systemic therapy
History of other cancers other than non-melanoma skin cancer
Actionable mutations on tumor genomic sequencing will be ineligible, and those participants encouraged to proceed with the relevant targeted therapy
Parallel
Neratinib + endocrine therapy
DrugNeratinib 120mg daily for 1 week, 160mg daily for 1 week and then 240mg daily thereafter
Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant
DrugEndocrine therapy with out without CDK4/6 inhibitor
CDK4/6 + Endocrine therapy
DrugEndocrine therapy with or without CDK 4/6 inhibitor
Median Progression-Free Survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse events will be quantified using the CTCAE v4.0 every 3 months
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This trial is not recruiting at the moment. You can still explore other options:
