NCT01917279

Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC

A Randomized Phase III Study of Metronomic vs. Intermittent Capecitabine Maintenance Therapy Following First-line Capecitabine and Docetaxel Therapy in HER2-negative Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Binghe Xu · Unknown
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).

Conditions

• Breast Neoplasms
• Neoplasms by Site
• Neoplasm Metastasis
• Breast Diseases
• Skin Diseases

Interventions

Type	Name	Description
DRUG	Docetaxel plus Capecitabine	Eligible patients will receive treatment with Capecibatine (1000 mg/ m2 twice daily D1-14 Q3W) plus docetaxel(75 mg/m2, D1,Q3W) for a maximum of 6 cycles, or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration. For the the patients with SD, PR or CR after initiate treatment phrase will enter into maintenance treatment phase.
DRUG	Intermittent Capecitabine	Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle
DRUG	Metronomic Capecitabine	Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

Timeline

• Start date: 2013-10-01
• Primary completion: 2020-07-01
• Completion: 2021-07-01
• First posted: 2013-08-06
• Last updated: 2020-07-23

Locations

1 site across 1 country: China