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A Phase I-II Study of Interferon-gamma Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients with HER-2 Positive Breast Cancer
This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab. This study will also look at other effects of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab, including its effect on this type of cancer. Interferon-gamma is a biologically manufactured protein that is similar to a protein the body makes naturally. In the body, interferon gamma is produced by immune cells and helps to prevent serious infections.
Primary Objectives - Phase 1: - To evaluate the safety and tolerability of the combination of IFN-γ with paclitaxel, trastuzumab and pertuzumab for 12 weeks and determine the recommended phase II dose (RP2D) in patients with metastatic breast cancer. Phase 2: - To evaluate the pathologic complete response rate (pCR) after combination of IFN-γ with paclitaxel, trastuzumab and pertuzumab for 12 weeks of neoadjuvant therapy in patients with clinical stage 2-3 HER2 positive breast cancer. Secondary Objectives - Phase 1: - To evaluate overall response rate (OR, CR+PR) using standard response evaluation criteria in solid tumors (RECIST) version 1.1. - To evaluate median progression free survival (PFS). Phase 2- To evaluate safety and tolerability of the combination therapy - To evaluate the PFS. Exploratory Objectives - (A) Determine whether IFN-ã combination therapies restore anti-HER-2 CD4 Th1 response. (B) Change the tumor associated immune response. (C) Change the known tumor biomarkers that predict response in the HER-2 positive breast cancer.