At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed operable invasive adenocarcinoma of the breast, T1–T3, HER2 negative
- ✓At least 1 positive axillary lymph node; eligible TNM stages N1a, N2a, or N3a
- ✓Mastectomy or conservative surgery with axillary dissection; margins free of disease
- ✓Randomization within 60 days of surgery
- ✕Prior systemic therapy for breast cancer
- ✕Prior anthracycline or taxane therapy (paclitaxel or docetaxel) for any malignancy
- ✕Prior radiotherapy for breast cancer
- ✕Bilateral invasive breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Docetaxel, Capecitabine, and 2 other interventions for Breast Cancer. Completed, enrolled 1,384 participants across 58 sites.
Detailed 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.