Originally published as JCO Early Release 10.1200/JCO.2006.09.9994 on May 21 2007

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Multicenter Phase II Trial of Neoadjuvant Therapy With Trastuzumab, Docetaxel, and Carboplatin for Human Epidermal Growth Factor Receptor-2–Overexpressing Stage II or III Breast Cancer: Results of the GETN(A)-1 Trial

Bruno P. Coudert, Remy Largillier, Laurent Arnould, Philippe Chollet, Mario Campone, David Coeffic, Frank Priou, Joseph Gligorov, Xavier Martin, Véronique Trillet-Lenoir, Béatrice Weber, Jean Pierre Bleuse, Berangère Vasseur, Daniel Serin, Moïse Namer

From the Departments of Oncology and Pathology, CAC G.F. Leclerc and IFR 100, Dijon; Oncology, CAC A. Lacassagne, Nice; Oncology, CAC J. Perrin, Clermont Ferrand; Oncology, CAC R. Gauducheau, Nantes; Oncology, Clinique du Mail, Grenoble; Oncology, CH Les Oudairies, La Roche sur Yon; Oncology, Cancer Est, APHP Tenon; Oncology, Sanofi-aventis, Paris; Oncology, Clinique St Marie, Chalon sur Saone; Université Lyon 1, EA3738 et CH Lyon Sud, Lyon; Oncology, CAC A Vautrin, Nancy; Oncology, Roche, Neuilly; and Oncology, Institut St Catherine, Avignon, France

Address reprint requests to Bruno P. Coudert, MD, Centre GF Leclerc, 1 rue du Pr Marion, 21000 Dijon, France; e-mail: bcoudert{at}dijon.fnclcc.fr

Purpose Trastuzumab plus chemotherapy has become the standard of care for human epidermal growth factor receptor-2 (HER-2) –positive breast cancer. Trastuzumab-based preoperative systemic therapy (PST; neoadjuvant therapy) also appears promising, warranting further investigation.

Patients and Methods Patients with HER-2-positive, stage II/III, noninflammatory, operable breast cancer requiring a mastectomy (but who wanted to conserve the breast) received trastuzumab 4 mg/kg (day 1), followed by 2 mg/kg weekly, plus docetaxel 75 mg/m² every 3 weeks, and carboplatin (area under curve, 6) for six cycles before surgery. The primary end point was pathologic complete response (pCR) rate, determined from surgical specimens.

Results Seventy patients were enrolled. Most patients had clinical T2/T3 tumors (100%) or clinical N1/2 nodes (53%). Sixty-seven patients (96%) completed six cycles of therapy, one patient withdrew due to progressive disease, and two patients withdrew for toxicity. A complete or partial objective clinical response occurred in 95% of patients (85% and 10%, respectively). Surgery was breast conservative in 45 (64%) of 70 patients. In an intent-to-treat analysis, tumor and nodal pCR were seen in 27 (39%) of 70 patients. Centralized retrospective analysis of HER-2 status demonstrated a 43% pCR rate in the 24 of 56 confirmed HER-2-overexpressing (3+) and/or fluorescence in situ hybridization–positive tumors. Treatment was generally well tolerated. Grade 3/4 neutropenia and febrile neutropenia were uncommon (2%). Two patients withdrew prematurely due to a transient, asymptomatic decrease in left ventricular ejection fraction. No symptomatic cardiac dysfunction occurred.

Conclusion PST with trastuzumab plus docetaxel and carboplatin achieved promising efficacy, with a good pCR rate and favorable tolerability in stage II or III HER-2-positive breast cancer.

published online ahead of print at www.jco.org on May 21, 2007.

Presented at the 28th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 8-11, 2005.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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