Safety and activity of docetaxel and trastuzumab in HER2 overexpressing metastatic breast cancer a pilot phase ii study

Filippo Montemurro, Gabriella Choa, Roberto Faggiuolo, Elisa Sperti, Antonio Capaldi, Michela Donadio, Monica Minischetti, Attilio Salomone, Guido Vietti-Ramus, Oscar Alabiso, Massimo Aglietta

Research output: Contribution to journalArticle


We conducted a pilot phase II trial of trastuzumab administered concurrently with docetaxel in women with HER2-overexpressing advanced breast cancer. Twenty-five women with HER2-positive (3+ by immunohistochemistry = 16, 2+ = 9) metastatic breast cancer received docetaxel (75 mg/m2 every 3 weeks for 6 cycles) and trastuzumab (4 mg/kg loading dose, 2 mg/kg weekly thereafter). Twenty-three patients (92%) had visceral metastatic involvement. Twenty-three patients had received prior chemotherapy as part of adjuvant (18), metastatic (2), and both (3) treatment. The number of cycles administered was 121 (median 6, range 1-6). Symptomatic cardiotoxicity (GIII) occurred in one patient. The most common grade GIII/IV toxicity was neutropenia (80% of the cycles), although febrile neutropenia did not occur. No other GIII/IV toxicities were observed. Response rate was 70% (1 complete response and 15 partial responses) in 23 evaluable patients. The combination of docetaxel and trastuzumab is well tolerated and has clinically meaningful antitumor activity.

Original languageEnglish
Pages (from-to)95-97
Number of pages3
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number1
Publication statusPublished - Feb 2003



  • Docetaxel
  • Metastatic breast cancer
  • Trastuzumab

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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