NCT00129935

EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer

Phase III Trial to Compare Epirubicin and Cyclophosphamide (EC) Followed by Docetaxel (T) to Epirubicin and Docetaxel (ET) Followed by Capecitabine (X) as Adjuvant Treatment, Node Positive Breast Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,384 (actual)
• Sponsor: Spanish Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Estimation of the 5-year disease-free survival in the control arm is 72%. The experimental arm is expected to increase the 5-year disease-free survival by 7% (up to 79%). With an alpha error of 0.05 and 80% power, 592 patients per arm are needed. Assuming a 17% post-randomization drop-out, 691 patients per arm are needed.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel
DRUG	Capecitabine
DRUG	Epirubicin
DRUG	Cyclophosphamide

Timeline

• Start date: 2004-02-01
• Primary completion: 2013-06-01
• Completion: 2019-04-04
• First posted: 2005-08-12
• Last updated: 2023-03-31
• Results posted: 2019-10-25

Locations

58 sites across 1 country: Spain