Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer
Status:
Completed
Trial end date:
2017-11-06
Target enrollment:
Participant gender:
Summary
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.