NCT02012634

Metronomic Chemotherapy of Capecitabine After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer

A Multi-center, III Phase，Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 340 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer

Detailed description

Capecitabine comes as a tablet to take by mouth. It is usually taken twice a day (in the morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next dosage cycle. In this study, capecitabine will be prescribed as dosage of 900mg/m2, and maintain for a whole year after the standard treatment in operable triple negative breast cancer patients. DFS is set as the primary outcome, OS and DDFS are also observed as the secondary outcomes. Statistical analysis are made to see whether this metronomic therapy of capecitabine ( 900mg/m2) will bring benefit to any of the iterms above.

Conditions

• Breast Cancer
• Capecitabine
• Triple Negative Breast Cancer

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-12-01
• Completion: 2018-12-01
• First posted: 2013-12-16
• Last updated: 2014-11-13

Locations

1 site across 1 country: China