Women's MoonShot: Neoadjuvant Treatment With PaCT for Patients With Locally Advanced TNBC

PRIMARY OBJECTIVE: I. To evaluate the pathologic complete response (pCR), residual cancer burden (RCB)-0 and RCB-I rates of patients with localized TNBC who were treated with panitumumab, carboplatin and paclitaxel (PaCT) in the neoadjuvant setting. SECONDARY OBJECTIVES: I. To estimate progression free survival (PFS) distribution of localized TNBC patients who were non-responders to initial anthracycline and cyclophosphamide chemotherapy, and who were treated with the PaCT regimen in the neoadjuvant setting. II. Determine changes of epidermal growth factor receptor (EGFR) downstream biomarkers one week after 1 dose of panitumumab. III. Determine response rate after 4 cycles of PaCT using radiographic imaging. IV. Correlate pathologic response with EGFR expression as measured by immunohistochemistry (IHC). V. Determine toxicity associated to 4 cycles of PaCT in the neoadjuvant setting. VI. Compare pathologic response to 4 cycles of PaCT in EGFR overexpressing tumors versus (vs.) non-EGFR overexpressing tumors. VII. Compare pathologic response in tumors to 4 cycles of PaCT vs. 12 weeks of weekly paclitaxel (using data collected in conjunction with protocol 2014-0185). EXPLORATORY OBJECTIVES: I. Determine the correlation between EGFR expression by IHC and the presence of enhanced EGFR gene signatures at the time of initial tumor biopsy prior to neoadjuvant setting (NACT) (using gene expression data obtained from the protocol 2014-0185). II. Determine rates of pCR in patients with EGFR overexpressed tumors identified by gene signatures (using gene expression data obtained from protocol 2014-0185) and compare to pCR rates in non-EGFR overexpressed tumors. III. Determine the correlation between EGFR expression by IHC and the changes of EGFR downstream changes induced in surgery sample after completion of PaCT regimen. IV. Determine the change in programmed cell death ligand 1 (PD-L1) glycosylation induced by panitumumab, and correlation with efficacy. V. Determine the change after treatment in blood-based markers, if any, and use these to predict a response to panitumumab treatment. OUTLINE: Patients receive panitumumab intravenously (IV) over 30 minutes and paclitaxel IV over 30 minutes on days 1, 8, and 15. Patients also receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3-4 months.