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Is docetaxel (Taxotere®) or vinorelbine (Navelbine®) better for the treatment of early breast cancer?

April 24, 2010

Study:  Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatment of breast cancer: Final reports of the FinHer trial.

Study Design:  A randomized, controlled, open-label phase III trial

Study Eligibility:  Women aged 65 years or younger who had undergone mastectomy or breast conserving surgery with axillary nodal dissection for invasive breast cancer. 

Enrollment: 1,010 women

The FinHer (Finland Herceptin®) trial was an open, phase III trial that looked at 1,010 women with node-positive or high-risk node-negative breast cancer.  Two hundred thirty-two women with Her2-positive breast cancer were assigned to receive trastuzumab (Herceptin®) for 9 weeks with docetaxel (Taxotere®) or vinorelbine (Navelbine®) or only docetaxel or vinorelbine.  The primary endpoint of the trial was distant-disease-free survival (DDFS), defined as the time period from the date of randomization to the date of first cancer recurrence other than the breasts or death if occurring before distant recurrence.  Secondary endpoints included adverse effect and overall survival.  Women were recruited from October 2000 to September 2003.       

Women treated with docetaxel had better DDFS than those treated with vinorelbine. But there was no difference in overall survival between the two groups.  Her2-positive women treated with trastuzumab plus chemotherapy had better DDFS than those treated with chemotherapy only.  But there was no difference in overall survival when adding trastuzumab to chemotherapy. 

This phase III trial was conducted to evaluate whether cardiotoxicity may be limited when trastuzumab is administered for a short time period before anthracyclines are given.  But the study population size was inadequate to answer the question as small number of patients who were Her2-positive participated in the trial.  Patients treated with trastuzumab did not have a decline in their cardiac function and actually had slightly better function than patients treated with chemotherapy only; however, this difference may be a chance finding and not due to shorter duration of treatment with trastuzumab. 

Click here for access to the original journal article.