Carboplatin and Paclitaxel with or without Panitumumab in Treating Patients with Invasive Triple Negative Breast Cancer

Active:	No
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT02876107
Trial Phases:	Phase II	Protocol IDs:	2016-0177 (primary) NCI-2017-00619
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	M D Anderson Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT02876107

Summary

This randomized phase II trial studies how well carboplatin and paclitaxel with or without panitumumab work in treating patients with invasive triple negative breast cancer. Drugs used in the chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping the them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Giving carboplatin and paclitaxel with or without panitumumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Objectives

PRIMARY OBJECTIVE:
I. To determine the pathologic complete response (pCR) rate in patients with primary triple-receptor negative (estrogen receptor [ER]-negative, progesterone receptor [PgR]-negative, and human epidermal growth factor receptor 2 [HER2]-negative) inflammatory breast cancer (TN-IBC) by using a combination of panitumumab, carboplatin, and paclitaxel (PaCT) in comparison with carboplatin and paclitaxel (CT) followed by adriamycin and cyclophosphamide (AC) in a neoadjuvant setting.

SECONDARY OBJECTIVES:
I. To determine the disease-free survival (DFS) rates produced by either arm of trial combination treatment.
II. To determine the overall survival (OS) rates produced by either arm of trial combination treatment.
III. To determine the safety and tolerability of both arms of trial combination treatment.

EXPLORATORY OBJECTIVES:
I. To determine whether the pCR rate positively correlates with reduced nodal expression status.
II. To determine whether the pCR rate inversely correlates with arginine methylation status of epidermal growth factor receptor (EGFR).
III. To identify molecular biomarkers predictive of the pCR rate by analysis of multiplexed immunohistochemical (IHC) staining.
IV. To identify molecular biomarkers predictive of the pCR rate by genomic and proteomic analysis.
V. To determine whether the inhibition of the EGFR pathway downregulates the COX-2 pathway and mesenchymal marker.
VI. To identify cell types in tumor microenvironment that determine the response topanitumumab by single cell ribonucleic acid (RNA) sequencing.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP A: Patients receive panitumumab intravenously (IV) over 1 hour on day 1 of cycle 0 and over 30 minutes on days 1, 8, and 15 of cycles 1-4. Patients also receive paclitaxel IV over 1-3 hours on days 1, 8, and 15 of cycles 1-4, and carboplatin IV over 30 minutes on day 1 of cycles 1-4. Patients then receive standard of care doxorubicin IV over 90 minutes and cyclophosphamide IV over 90 minutes on day 1 of cycles 5-8. Treatment repeats every 21 days for up to 4 cycles (cycles 1-4) and then every 14-21 days for up to 4 cycles (cycles 5-8) in the absence of disease progression or unexpected toxicity.

GROUP B: Patients receive paclitaxel, carboplatin, doxorubicin, and cyclophosphamide as in Group A. Treatment repeats every 21 days for up to 4 cycles (cycles 1-4) and then every 14-21 days for up to 4 cycles (cycles 5-8) in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up at 1 month and then annually for at least 5 years.

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