(ChemotherapyAdvisor) – Triple-negative breast cancer shows modest response when treated with cetuximab in combination with carboplatin, according to a team of US-based researchers. This conclusion is based on a study entitled “TBCRC 001: Randomized Phase II Study of Cetuximab in Combination with Carboplatin in Stage IV Triple-Negative Breast Cancer,” which was published in the Journal of Clinical Oncology on July 20.  

In this study, the investigators aimed to develop a targeted therapy for triple-negative breast cancer (TNBC). To meet this aim, the investigators conducted this randomized, phase 2 trial, in which patients with metastatic TNBC received anti-EGFR antibody cetuximab (400mg/m2 load, then 250mg/m2, 1X/week, IV) alone, with carboplatin (area under the curve of 2, 1X/week, IV) added after progression or as concomitant therapy from the beginning until they reached end points of response rate (RR), time to progression (TTP), overall survival (OS), and toxicity.

The investigators reported the following results: RRs were 6% to cetuximab and 16% to cetuximab plus carboplatin after progression. RR to those treated from the beginning with cetuximab plus carboplatin was 17%; 31% of patients responded or had prolonged disease stabilization. The cetuximab plus carboplatin regimen was well tolerated, but both TTP and OS were short at 2.1 months (95% CI, 1.8–5.5 months) and 10.4 months (95% CI, 7.7–13.1 months), respectively. Sixteen patients had tumor biopsies before and 1 week after therapy; genomic patterns of the EGFR pathway showed activation in 13 and inhibition by therapy in 5.

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The investigators concluded: “Combination therapy including cetuximab plus carboplatin in metastatic TNBC produced responses in fewer than 20% of patients.”