This phase Ib/II trial studies the side effects and best dose of capecitabine when given together with neratinib and to see how well it works in treating patients with HER2 positive stage IV breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving capecitabine and neratinib may work better than capecitabine alone in treating patients with breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03377387.
PRIMARY OBJECTIVES:
I. To establish the safety and tolerability of capecitabine 7/7 and neratinib. (Phase Ib)
II. To assess for efficacy of capecitabine 7/7 and neratinib. (Phase II)
SECONDARY OBJECTIVES:
I. To evaluative safety and tolerability. (Phase II)
II. To assess for progression-free survival of capecitabine 7/7 and neratinib. (Phase II)
EXPLORATORY OBJECTIVES:
I. To collect research blood (i.e.: cell-free deoxyribonucleic acid [cfDNA]) to correlate with the response during treatment. (Phase II)
II. To assess quality of life while on the treatment with periodic questionnaires. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of capecitabine followed by a phase II study.
Patients receive neratinib orally (PO) once daily (QD) on days 1-28 and capecitabine PO every 12 hours (Q12H) on days 1-7 and 15-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorChau Thanh Dang
