TAC Versus TCX as Adjuvant Treatment for High-risk Her2-Negative Breast Cancer

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 or node-negative high-risk 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.

Timeline

Start

2011-05

Primary completion

2023-12

Completion

2023-12

Publications

• Song Y, Wang Y, Cao X, Xu Y, Zhou Y, Sun Q, Shen S. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide versus anthracycline plus docetaxel and cyclophosphamide regimen in women with high-risk, HER2-negative breast cancer: An open-label, randomized controlled trial. Cancer Commun (Lond). 2025 Sep;45(9):1113-1122. doi: 10.1002/cac2.70041. Epub 2025 Jun 9.
• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

Drugs

Indications