Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer

Summary

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.

Timeline

Start

2018-02-19

Primary completion

2025-05-13

Completion

2025-05-13

Publications

• Lim B, Marx A, Kai M, Alexander A, Bassett R Jr, Ma W, Willey J, Sun H, Nasrazadani A, Mohammad MM, Zhang J, Lucci A, Sun SX, Stauder MC, Whitman GJ, Le-Petross H, Valero V; MDACC Inflammatory Breast Cancer Team; Woodward WA, Layman RM. A phase Ib/II trial of neoadjuvant neratinib added to standard therapy in patients with HER2-positive or HR-positive/HER2-negative inflammatory breast cancer (including stage III and IV disease). Ther Adv Med Oncol. 2025 Oct 14;17:17588359251379392. doi: 10.1177/17588359251379392. eCollection 2025.

Drugs

Indications