A Randomized Phase II Study of Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer
Rationale: Previous studies have demonstrated the anti-tumor efficacy of gemcitabine and
trastuzumab against metastatic breast cancer when given alone and in combination. Yet,
research indicates that the two drugs given together work more effectively than either
alone. Laboratory studies testing the combination of trastuzumab and cisplatin have shown
synergistic anti-tumor activity with the two drugs. In addition, clinical studies suggest a
high level of anti-tumor activity with the combination of gemcitabine and cisplatin.
Researchers are testing the triple drug combination of gemcitabine, trastuzumab, and
cisplatin in the current study to evaluate the potential for enhanced responsiveness in
patients with Her-2/neu overexpressing breast cancer as well as comparing it to the double
drug combination of gemcitabine and trastuzumab.
Purpose: This study will measure patient responses and compare the efficacy of a double drug
combination (gemcitabine and trastuzumab) with a triple drug combination (gemcitabine,
trastuzumab, and cisplatin) in patients with metastatic breast cancer. Side effects will be
carefully assessed in patients.
Treatment: Patients in this study will receive one of two treatment combinations. A computer
will randomly assign patients to a treatment group. Group one will be given gemcitabine and
trastuzumab. Gemcitabine will be given to patients on days 1 and 8, and trastuzumab on days
1, 8, and 15. Group two will receive gemcitabine, trastuzumab, and cisplatin. Gemcitabine
and cisplatin will both be administered on days 1 and 8, and trastuzumab on days 1, 8, and
15. Each treatment cycle (for both groups) will last a total of 21 days. All study drugs
will be administered through intravenous infusions. Several tests and exams will be given
throughout the study to closely monitor patients. Thorough patient exams will be given at
the beginning of each treatment cycle. Imaging tests will be done every two cycles for the
first eight cycles and then every three cycles until study completion. Study treatment will
be discontinued due to disease growth or unacceptable side effects.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free progression
Kari Kendra, MD
Ohio State University
United States: Institutional Review Board
|Ohio State University||Columbus, Ohio 43210|