drugset / Trial / NCT03561740

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

NCT03561740 ↗

Phase 3 Recruiting 794 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2018-07-25
Primary completion
2023-06-15
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 500 mg Oral

Indications