Spots Global Cancer Trial Database for Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer

Study Description

Brief 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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