NCT02664103

Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Fixed-dose combination of capecitabine and cyclophosphamide SAR439281	Pharmaceutical form:Tablet Route of administration: Oral

Timeline

• Start date: 2016-01-23
• Primary completion: 2017-11-06
• Completion: 2017-11-06
• First posted: 2016-01-26
• Last updated: 2018-02-01

Locations

5 sites across 1 country: India