A Randomized Study of Weekly Vinorelbine (Navelbine®) Alone or in Combination With Trastuzumab (Herceptin®) (NSC-688097) for Patients With HER-2-Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane + Trastuzumab Combination Therapy - Phase III
- Compare progression-free survival (PFS) of women with HER2-positive progressive
metastatic breast cancer treated with vinorelbine with or without trastuzumab
- Compare overall survival and time to treatment failure in patients treated with these
- Compare the toxicity of these regimens in these patients.
- Compare the response rate (complete and partial, confirmed and unconfirmed) in patients
with measurable disease treated with these regimens.
- Correlate baseline circulating tumor cells (CTC) with PFS, overall survival, and
disease progression status at 9 weeks in patients treated with these regimens.
- Correlate 4-week CTC with subsequent PFS and overall survival of patients treated with
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm I: Patients receive trastuzumab (Herceptin®) IV over 90 minutes and vinorelbine IV
over 10 minutes on day 1 of course 1. Patients receive trastuzumab IV over 30 minutes
and vinorelbine IV over 10 minutes on days 1, 8, 15, and 22 in all subsequent courses.
If trastuzumab is discontinued due to toxicity, patients may continue to receive
- Arm II: Patients receive vinorelbine IV over 10 minutes on days 1, 8, 15, and 22.
In both arms, courses repeat every 28 days in the absence of disease progression or
After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 292 patients (146 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Lajos Pusztai, MD, MPH, DPhil
M.D. Anderson Cancer Center
United States: Federal Government