An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy with Trastuzumab in Triple Positive Breast Cancers
Objective
Primary Objective: Estimate the pathologic complete response (pCR) rate (defined as the lack of all signs of invasive cancer in the breast tissue [ypT0/Tis]) after 24 weeks of treatment, consisting of 3 weeks of initial treatment with neratinib alone, OR non-steroidal aromatase inhibitor (NSAI) alone, OR combined treatment with neratinib and NSAI, followed by 21 weeks of combined treatment with neratinib, NSAI, and trastuzumab in patients with triple positive breast cancers.
Secondary Objectives: Estimate the safety and tolerability of 24 weeks of treatment, consisting of 3 weeks of initial treatment with neratinib alone, OR non-steroidal aromatase inhibitor (NSAI) alone, OR combined treatment with neratinib and NSAI, followed by 21 weeks of combined treatment with neratinib, NSAI, and trastuzumab in patients with triple positive breast cancers. Estimate the pCR in the breast tissue and lymph nodes (ypT0/Tis ypN0) after 24 weeks of treatment, consisting of 3 weeks of initial treatment with neratinib alone, OR nonsteroidal aromatase inhibitor (NSAI) alone, OR combined treatment with neratinib and NSAI, followed by 21 weeks of combined treatment with neratinib, NSAI, and trastuzumab in patients with triple positive breast cancers. Estimate residual disease in the breast tissue after 24 weeks of treatment, consisting of 3 weeks of initial treatment with neratinib alone, OR non-steroidal aromatase inhibitor (NSAI) alone, OR combined treatment with neratinib and NSAI, followed by 21 weeks of combined treatment with neratinib, NSAI, and trastuzumab in patients with triple positive breast cancers using Residual Cancer Burden (MD Anderson). Estimate radiologic response using RECIST 1.1 in the breast tissue after 24 weeks of treatment, consisting of 3 weeks of initial treatment with neratinib alone, OR non-steroidal aromatase inhibitor (NSAI) alone, OR combined treatment with neratinib and NSAI, followed by 21 weeks of combined treatment with neratinib, NSAI, and trastuzumab in patients with triple positive breast cancers. Estimate the relative dose intensity during 24 weeks of treatment.
