Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer

The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.

Inclusion Criteria:

• histologically confirmed metastatic breast cancer overexpressing HER2
• pretreatment with anthracycline in either the adjuvant or palliative setting.
• HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.
• informed consent

Exclusion Criteria:

• more than 1 chemotherapy for advanced disease
• taxane or trastuzumab pretreatment
• brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status >1
• pregnancy or lactation, childbearing potential without reliable contraception
• clinically significant cardiac disease,
• neutrophils <1500/µl, platelets <75,000/µl
• total bilirubin and creatinine >1.5 × the upper limit of normal