Breast cancer Cancer Breast
Conditions
Interventions
Control arm: Epirubicin 90 mg/m^2 (day one) + Cyclophosphamide 600 mg/m^2 (day one)
four cycles, three weekly intervals followed by Paclitaxel 175 mg/m^2 (day one)
four cycles at three weekly intervals.
Research arm: Epirubicin 90 mg/m^2 (day one) + Cyclophosphamide 600 mg/m^2 (day one)
four cycles at three weekly intervals followed by Gemcitabine 1250 mg/m^2 (days one and eight) + Paclitaxel 175 mg/m^2 (day one)
four cycles at three weekly intervals.
Sponsors
The University of Birmingham (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of invasive breast carcinoma 2. Completely resected early stage disease 3. Definite indication for adjuvant chemotherapy 4. Any nodal status 5. Any hormone receptor status 6. Fit to receive either of the trial chemotherapy regimens. Adequate bone marrow, hepatic, and renal function. 7. Eastern Cooperative Oncology Group (ECOG) performance status of zero to two 8. Written informed consent 9. No previous chemotherapy or radiotherapy 10. Radiotherapy intent is known (this must be stated at the point of randomisation) 11. Randomisation within eight weeks of surgery, but ideally within one month 12. No previous malignancy except basal cell carcinoma or cervical carcinoma in situ, unless disease-free for ten years, after surgical treatment only 13. Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active 14. No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up
Exclusion criteria
Exclusion criteria: Any of the above criteria not satisfied
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Five-year disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Ten-year overall survival, toxicity, dose intensity, tolerability and serious adverse events | — |
Countries
United Kingdom
Outcome results
None listed