Purpose: Preclinical data indicate that the combination of docetaxel, cisplatin and trastuzumab (TCH) may have the potential for clinically significant activity against breast cancers that overexpress the her2/neu gene (HER2). An open-label phase II trial was designed to investigate the response rate and toxicity profile of TCH in breast cancer patients with a primary tumor 2-5 cm in diameter (T2) in its original size.
Methods: Thirty breast cancer patients with HER2-overexpressing tumors were enrolled. Patients received 6 cycles of docetaxel at 60 mg/m(2) and cisplatin at 50 mg/m(2) given on day 1 and then every 21 days. Trastuzumab was given on day 1, cycle 1 (4 mg/kg), and then continued weekly at 2 mg/kg for 1 year or until disease progression. Tumor measurements were obtained at baseline as well as after 3 and 6 cycles of chemotherapy.
Results: We identified 29 breast cancer patients in Taiwan, of whom 13 (44.8%) had pathological complete responses. No cardiac toxicity was observed. Hematologic grade 4 or 3 toxicities were observed in 1 of 28 patients. Non-hematologic grade 4 or 3 toxicities with a reverse pattern were observed in 6 of 29 patients.
Conclusions: The results of our study indicate that TCH neoadjuvant chemotherapy is feasible and active in T2 HER2-overexpressing breast cancer patients in terms of pathological complete response rate, complete response, partial response and manageable toxicities.