At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed breast adenocarcinoma, potentially curable, T0-4 N0-2 M0, without clinical T4 disease
- ✓Prior surgery: total or partial mastectomy with level II axillary node dissection (or sufficient nodal sampling if sentinel node positive)
- ✓Axillary node-positive disease OR node-negative disease with tumor ≥1 cm AND at least one high-risk feature (grade III, ER-negative, or lymphatic/vascular invasion)
- ✓Age ≤60 years, female, premenopausal or postmenopausal
- ✕Clinical T4 disease
- ✕Residual tumor in axilla after dissection
- ✕Prior chemotherapy for breast cancer
- ✕Prior hormonal therapy for breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Adjuvant Trial Of Sequenced EC + Filgrastim + Epoetin Alfa Followed By Paclitaxel Versus Sequenced AC Followed By Paclitaxel Versus CEF As Therapy For Premenopausal Women And Early Postmenopausal Women Who Have Had Potentially Curative Surgery For Node Positive Or High Risk Node Negative Breast Cancer
In Brief
A Phase 3 clinical trial evaluating epoetin alfa, filgrastim, and 5 other interventions for Breast Cancer. Completed, enrolled 2,104 participants across 78 sites in 2 countries.
Detailed Summary
RATIONALE: 1. . To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease. 2. . It is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy given with or without epoetin alfa in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
Study Details
Timeline
Interventions
40,000 IU
5 mg/kg/d - days 2-13
75, 600 and 830 mg/m2
60 mg/m2
60 mg/m2
500mg/m2
175 mg/m2