INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer
1. Determine the response rate with this regimen in an anthracycline and taxane resistant
cohort of patients.
2. Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and
carboplatin for this patient population.
3. Determine the time to relapse after the administration of this regimen.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study.
disease progression or unacceptable toxicities
Ian Rabinowitz, MD
University of New Mexico
United States: Institutional Review Board
|University of New Mexico||Albuquerque, New Mexico 87131|