A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin and trastuzumab for T2 breast cancers.

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.