Stopped: \<75% accrued
This phase I/II trial studies the side effect and best dose of neratinib and to see how well it works with paclitaxel and with or without pertuzumab and trastuzumab before combination chemotherapy in treating patients with breast cancer that has spread to other places in the body (metastatic). Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with pertuzumab and trastuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, 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. Giving neratinib, pertuzumab, trastuzumab, paclitaxel and combination chemotherapy may work better in treating patients with breast cancer.
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Dose-Limiting Toxicities (DLTs) During Dose Escalation
Timeframe: From treatment initiation through completion of 2 cycles (approximately 6 weeks)
Pathologic Complete Response (pCR) in HER2+ Metastatic or Locally Advanced IBC in Cohort I Phase II
Timeframe: At surgery following completion of neoadjuvant therapy (approximately 18-24 weeks from treatment initiation).
Pathologic Complete Response (pCR) in HER2-Negative / HR-Positive IBC in Cohort II
Timeframe: At the time of surgery (mastectomy), following completion of neoadjuvant therapy; approximately 18-24 weeks from treatment initiation.