A Study of the Addition of Metronomic Capecitabine to Standard Adjuvant Therapy in High Risk HER2+ BC paTients

Breast cancer is the most common malignant tumor in women. Recurrent or metastatic breast cancer is incurable. High risk patients usually have the following characteristics, such as, non-pCR after neoadjuvant therapy, lymph nodes positive, \>2cm tumor size, HER2 overexpression, etc. Intensive targeted or chemo therapy could improve prognosis. Previous studies have shown the efficacy and feasibility of intensive treatment of capecitabine in non-pCR breast cancer patients. Given the metronomic capecitabine therapy is well tolerated, we designed this study to compare the efficacy and safety of adding metronomic capecitabine to standard adjuvant therapy for high risk HER2+ breast cancer patients.

NCT Number	NCT03561740
Lead Sponsor	Sun Yat-sen University
Conditions	Breast Cancer
Enrollment	794 participants
Start Date	2018-07-25
Primary Completion	2023-06-15 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2018-07-26