A Phase II Study of Gemcitabine in Combination With Vinorelbine vs. Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer
This is an open-label, randomized, two-arm, parallel group phase II study. Eligible patients
will be randomized to each of the two treatment regimens, one of which is gemcitabine and
vinorelbine combination therapy (Group A) and the other is gemcitabine monotherapy followed
by vinorelbine monotherapy (Group B). Patients In group A monotherapy will receive
gemcitabine and vinorelbine in combination, while patients in group B will receive
gemcitabine monotherapy until the evidence of disease progression followed by vinorelbine. A
total of 82 patients will be enrolled in this study. Patients will be randomized after
stratified according to the number of prior chemotherapy including adjuvant chemotherapy and
visceral disease. No maximum number of cycles is pre-determined. Patients may continue on
study therapy until documented treatment failure.
Patients in group A who discontinue study therapy will proceed to the post-therapy follow-up
phase of the study. Patients in group B who discontinue study therapy while treated with
gemcitabine will proceed to receive vinorelbine on disease progression. Patients on
vinorelbine who discontinue study therapy will proceed to the post-therapy follow-up phase
of the study. Further treatment upon discontinuation of study therapy is at the discretion
of the investigator.
A two arm, open label phase II study without control is appropriate for exploring the
efficacy of gemcitabine with concurrent or sequential vinorelbine in this patient population
and for evaluating and characterizing toxicities of two treatment approaches, qualitatively
and quantitatively. The purpose of randomization in this phase II study is to diminish the
possible impact of selection bias on treatment outcome and thus on interpretation of
efficacy and safety data.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate
3 years
Yes
Jungsil Ro, MD, PhD
Principal Investigator
National Cancer Center, Korea
Korea: Food and Drug Administration
NCCCTS-04-092
NCT00532623
May 2004
October 2006
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