Breast Cancer Metastatic Clinical Trial
Official title:
A Phase II Open-label Randomized Study of a Fixed-dose Combination of Capecitabine and Cyclophosphamide Administered at Different Doses/Regimens With Metronomic Schedule in Patients With Metastatic Breast Cancer
Primary Objectives:
- To assess the safety for each cohort of patients on a fixed-dose combination pill of
capecitabine and cyclophosphamide administered at flat dose and with metronomic schedule
(defined as continuous daily treatment without interruption) in patients with metastatic
breast cancer.
- To assess the pharmacokinetics (PKs) and bioavailability of the fixed-dose combination
pill of capecitabine and cyclophosphamide administered at different doses/regimens by
metronomic schedule in patients with metastatic breast cancer.
Secondary Objectives:
- To assess antitumor activity of the fixed-dose combination pill of capecitabine and
cyclophosphamide administered at different doses/regimens by metronomic schedule in
patients with metastatic breast cancer given at 3 different doses and schedules (regimen
1=standard dose twice daily [BID], regimen 2=full dose once daily [OD], regimen 3=low
dose [OD])
- Disease Control Rate (DCR)
- Overall Response Rate (ORR)
- Time to Progression (TTP) using the Response Evaluation Criteria in Solid Tumors
(RECIST) criteria (version 1.1).
- To evaluate the compliance under treatment.
- To describe evolution of toxicities.
- To assess safety all along patient's treatment.
Primary objective will be evaluated at 12 weeks. Patients who show evidence of efficacy will be treated and followed-up until progression of the disease. ;
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