EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer
Status:
Completed
Trial end date:
2019-04-04
Target enrollment:
Participant gender:
Summary
This is a prospective, randomised phase III trial, to compare the efficacy and safety
profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor
receptor 2 (HER2) negative, node positive breast cancer patients.
Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4
cycles of T 100 mg/m2 day 1 every 3 weeks.
Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by
4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a
one-week rest period.
Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen
after the end of chemotherapy.
Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or
aromatase inhibitors (or both) after the end of chemotherapy.
Patients may receive radiotherapy when clinically indicated.