Overview

TAC Versus TCX as Adjuvant Treatment for Node-Positive Her2-Negative Breast Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Some sub-analysis has shown anthracycline-based regimens are not effective in Her-2 negative breast cancer, while capecitabine is more effective in this group of patients. This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for HER2 negative, node positive breast cancer patients. Control Arm: This includes 6 cycles of TAC 75/50/500 mg/m2 day 1 every 3 weeks. Experimental Arm: This includes 6 cycles of TC 75/500 mg/m2, day 1 every 3 weeks, concurrently with capecitabine 950 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period. Women with hormone receptor positive tumours must receive 5 years endocrine after the end of chemotherapy. Patients may receive radiotherapy when clinically indicated.
Phase:
Phase 3
Details
Lead Sponsor:
Peking Union Medical College Hospital
Treatments:
Capecitabine
Cyclophosphamide
Docetaxel
Doxorubicin
Liposomal doxorubicin