591 Background: The NSABP has confirmed the role of neoadjuvant chemotherapy for the treatment of women with breast cancer. NSABP B18 has demonstrated a relationship between complete pathological response (pCR) and a better survival. Recently Buzdar and colleagues reported a 65% pCR rate with six months of neoadjuvant chemotherapy plus trastuzumab in 23 women with breast cancer. Methods: We report the results of a trial in which women with stage IIB-IIIB and locoregional stage IV (LCRSIV) breast cancer with HER2 overexpression (by fluorescence in situ hybridization) were treated with docetaxel (D) 60 mg/m2 and vinorelbine (V) 45 mg/m2 administered every two weeks with weekly trastuzumab (12 weeks only), G-CSF and quinolone prophylaxis for six cycles prior to surgery. Results: Accrual has been completed and 31 patients (pts) have been enrolled. Age range 27–65. Stage II-12, Stage III-18, LCRSIV-1. Sixty-eight percent of pts had T3 or T4 tumors. Ninety percent of patients had clinically palpable lymph nodes. The average tumor size was 6.6 cm. All patients have completed their preoperative therapy and are evaluable for both clinical and pathological response. Grade 3/4 toxicity has included neutropenic fever 7/31 (23%). There has been no dominant grade 3/4 non-hematologic toxicity. Eight patients have required dose reduction (26%). There were 26 (84%) complete responses (cCr) and 3 (10%) partial responses (PR), one patient with stable disease (3%) and one pt has progressed in the breast only (3%). Pathological data demonstrates a pathologic complete response (pCR) in 14 pts (45%) by NSABP criteria (T0, Tis, NX) and in 12 pts (39%) by other criteria (T0, Tis, N0), 6 additional pts had residual T1a tumors at the time of surgery (65%). Conclusions: The overall clinical response rate is 88% with a cCR rate of 65%. The pCR rate of 45% with 65% of patients having a residual T1a or T0 lesion is among the highest response rates reported with preoperative chemotherapy. This supports the findings of Buzdar and colleagues considering that they treated patients with smaller tumors and utilized six months of therapy including an anthracycline. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech, sanofi-aventis Genentech, GlaxoSmithKline, Pierre Fabre, sanofi-aventis Genentech, GlaxoSmithKline, sanofi-aventis
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Jahanzeb et al. (2005) studied this question.