Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer

Francisco J. Esteva*, Vicente Valero, Daniel Booser, Laura T. Guerra, James L. Murray, Lajos Pusztai, Massimo Cristofanilli, Banu Arun, Bita Esmaeli, Herbert A. Fritsche, Nour Sneige, Terry L. Smith, Gabriel N. Hortobagyi

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

510 Scopus citations


Purpose: To evaluate the safety and efficacy of weekly docetaxel plus trastuzumab in women with HER-2-overexpressing metastatic breast cancer. Efficacy was correlated with serum HER-2 extracellular domain (ECD) levels. Patients and Methods: Thirty women with metastatic breast cancer were treated with weekly docetaxel and trastuzumab as first- or second-line therapy. Both docetaxel 35 mg/m2/wk and trastuzumab 2 mg/kg/wk were delivered in 4-week cycles consisting of three weekly treatments followed by 1 week of rest. A loading dose of trastuzumab 4 mg/kg was administered 1 day before the start of the first cycle. Results: The median delivered dose-intensity of docetaxel was 24 mg/m2/wk (range, 18 to 27 mg/m2/wk). The intent-to-treat overall response rate (ORR) was 63% (95% confidence interval [CI], 44% to 80%). The ORR in patients whose tumors were HER-2-positive by fluorescence in situ hybridization was 67% (16 of 24 patients; 95% CI, 45% to 84%). In patients with elevated serum HER-2 ECD at baseline, the ORR was 76% (95% CI, 53% to 92%), compared with 33% (95% CI, 7% to 70%) in patients with low HER-2 ECD levels (P = .04). Variations in HER-2 ECD concentrations during treatment correlated with response to treatment. Median time to progression was 9 months. Acute toxicity, including myelosuppression, was mild. Fatigue, fluid retention, and excessive tearing became more common with repetitive dosing. Conclusion: Weekly docetaxel and trastuzumab is an active combination for treating patients with HER-2-overexpressing metastatic breast cancer. Serum HER-2 ECD testing may be a promising method for monitoring patients on trastuzumab-based therapy.

Original languageEnglish (US)
Pages (from-to)1800-1808
Number of pages9
JournalJournal of Clinical Oncology
Issue number7
StatePublished - Apr 1 2002

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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