Abstract

520 Background: In patients (pts) with metastatic BC, trastuzumab [Herceptin (H)] in combination with CT results in higher response rates, longer control of disease, and superior survival. The objective of this study was to determine whether the addition of H to CT in the neoadjuvant setting could increase PCR rate in pts with HER/2 positive disease. Methods: 42 pts with HER/2-positive disease (IHC 3+ or FISH +) with operable BC were randomized to 4 cycles of P followed by 4 cycles of FEC, or the same CT with simultaneous weekly H at 2 mg/kg for 24 weeks.The primary objective was to demonstrate a 20% improvement in PCR (assumed 21% to 41%) with addition of H to CT. At the end of CT±H, pts had definitive surgery. The planned sample size was 164 pts. Results: Prognostic factors were similar in the two groups. After 34 pts had completed therapy, the trial's Data Monitoring Committee stopped the trial for superiority of CT + H. PCR rates were 25% and 67%, respectively, for CT alone (n=16) and CT + H (n=18) (P=0.02). Additional results are included in the table. Fever during neutropenia occurred in 9 and 11 pts, respectively, in CT alone and CT + H. Of those, 3 pts in each subgroup were hospitalized. Decrease in cardiac ejection fraction (>10%) was observed in 6 and 4 pts, respectively, in CT and CT + H. No pts had clinical CHF or other clinically relevant cardiac toxicity. Troponin-T levels remained normal in all pts. The trial was stopped by an independent DMC based on a Bayesian predictive probability of 0.95 that the trial would conclude a significant benefit for CT+H if completed to originally planned 164 pts. Conclusions: Despite the small sample size, these data indicate that adding H to CT as utilized in this trial significantly increased PCR without clinical CHF. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech Genentech Genentech

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