EC (Epirubicin, Cyclophosphamide) Followed by T (Docetaxel) Versus ET (Epirubicin, Docetaxel) Followed by X (Capecitabine) as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer 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 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. 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Randomized 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 for Operable, Node Positive Breast Cancer Patients|
- 5-year disease-free survival
- Overall survival
- Quality of life
- Single nucleotide polymorphisms (SNPs) as treatment predictive factors
- Molecular prognostic markers in tissue
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||February 2012|
|Spanish Breast Cancer Research Group (GEICAM)|
|San Sebastián de los Reyes, Madrid, Spain, 28700|
|Study Chair:||Miguel Martín, MD., PhD.||Spanish Breast Cancer Research Group (GEICAM)|