At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Docetaxel plus Capecitabine, Intermittent Capecitabine, and 1 other intervention for Breast Neoplasms and 4 related conditions. Targeting 280 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
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.
Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle
Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle