Prelimenary results of a phase I/II of a combination of cetuximab and taxane for triple negative breast cancer patients

e12018 Background: The triple negative subtype of breast cancer is currently only treated with chemotherapeutic agents. It has been demonstrated that over 50% of this kind of tumors express EGFR (HER-1). Cetuximab is a humanized antiEGFR IgG1 antibody. In colon cancer there are also high percentage of EGFR expression and addition of Cetuximab to chemotherapy results in renewed sensitivity to treatments. We therefore hypothesized that in a similar manner addition of Cetuximab to taxanes which are among the most potent anti breast cancer drugs will result in increased effectiveness in this subset of breast cancer patients. Methods: From January 2007 to January 2009, we treated 12 breast cancer patients with either paclitaxel 80 mg/m2, (10 patients) or docetaxel (30 mg mg/m2) (2 patients), with cetuximab weekly. Patients had a pathology sample of breast cancer with triple negative components, metastatic disease and up to two prior chemotherapy lines in the metastatic settings. Results: Patient characteristics (median): age 60 (31–69) years, prior taxane therapy 9/12 pts. Toxicity: Dermatologic grade 2 9/12 grade 3 3/12, nail disease grade 2 10/12 evaluable patients. One patient developed severe swallowing difficulties after 19 month of therapy which may or may not be linked to the treatment. Response is evaluable for 11/12 patients. Response which includes clinical response, tumor marker decrease, and a metastasis size decrease was noted in 9/11 patients. Including tumor marker normalization and nearly a roentgoenolgic CR in a young patient previously treated with several chemeotherapietic lines. Three patients developed brain metastasis during treatments. Molecular pathology is now performed. We continue accrual. Conclusions: Administration of taxane-cetuximab weekly therapy for triple negative breast cancer patients is possible. Toxicity is the cumulated expected toxicity of each of the agents — special care should be taken for nail disease which occurred in most of the patients. Some impressive clinical responses were obtained even in taxane pretreated patients. [Table: see text]