A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer
OBJECTIVES: Phase II Study:
- Compare the response rate in women with previously treated metastatic breast cancer
treated with capecitabine vs vinorelbine.
- Compare the duration of response in patients treated with these drugs.
Phase III Study:
- Compare overall and progression-free survival in patients treated with these drugs.
- Compare time to treatment failure in patients treated with these drugs.
- Compare overall safety of these drugs in these patients.
- Compare quality of life and clinical benefit response in patients treated with these
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and taxane resistance (refractory vs resistant vs sensitive).
- Phase II: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive vinorelbine IV on days 1 and 8. Courses repeat every 21
- Arm II: Patients receive oral capecitabine twice daily on days 1-14. Courses
repeat every 21 days.
In both arms, treatment continues in the absence of progression or unacceptable toxicity.
If sufficient response rate is determined in phase II, the phase III study is initiated.
- Phase III: Patients are randomized and receive treatment as in phase II. Quality of
life is assessed prior to randomization, at weeks 3, 6, 9, 18, 24, and 30, and then
every 12 weeks until disease progression.
Clinical benefit response is assessed daily while patient is on study.
Patients are followed every 6 weeks until disease progression and then every 12 weeks
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for phase
II of this study and a total of 406-452 patients (203-226 per treatment arm) will be accrued
for phase III of this study within 18.5 months.
Allocation: Randomized, Primary Purpose: Treatment
Martine J. Piccart-Gebhart, MD, PhD
Institut Jules Bordet
United States: Federal Government