Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is an open -label randomized phase II study of dose-dense Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2 (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreated patients with early breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central European Cooperative Oncology Group
• Treatments: Cyclophosphamide; Epirubicin; Fluorouracil

Criteria

Inclusion Criteria:

• patients with histological diagnosis of invasive breast cancer

• Patients with early stage I, II,III breast cancer amendable for complete surgical resection.

• Patients with any nodal status

• Patients with ER and PR -negative tumors. In case of axillary involvement:any hormonal receptors status.

• perfomance Status 0-1 on the ECOG Scale

• patients indicated for adjuvant chemotherapy

• No previous chemotherapy or radiotherapy

• Patients have to be randomized within 8 weeks after surgery. Its recommended that patients will start chemotherapy within 1 month after surgical treatment.

Exclusion Criteria:

• active infection

• pregnancy/breast feeding

• serious concomitant systemic disorders incompatible with the study

• Second primary malignancy (expect in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)

• Use of any other investigational agent within 4 weeks before enrollment into the study

• Cocurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy