Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment

• Status: Completed
• Trial end date: 2013-03-06
• Target enrollment: 0
• Participant gender: Female

Summary

This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:

• TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.

• FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Breast Cancer Research Group
• Collaborator: Sanofi
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Fluorouracil; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Written informed consent

• Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria.

• Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.

• Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.

• Patients without proven metastatic disease.

• Estrogen and progesterone receptors performed on the primary tumour prior to randomization.

• Age between 18 years and 70 years.

• Karnofsky performance status index > 80 %.

• Adequate hepatic, renal and heart functions.

• Adequate hematology levels.

• Negative pregnancy test

Exclusion Criteria:

• Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).

• Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.

• Prior radiation therapy for breast cancer.

• Bilateral invasive breast cancer.

• Pregnant, or lactating patients.

• Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment .

• Any T4 or N1-3 or M1 breast cancer.

• Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.

• Other serious illness or medical condition

• Past or current history of neoplasm other than breast carcinoma.

• Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.

• Lobular carcinoma in-situ (LCIS) of the breast.

• Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose

• Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.

• Definite contraindications for the use of corticosteroids.

• Concurrent treatment with other experimental drugs.

• Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.

• Concurrent treatment with any other anti-cancer therapy.

• Male patients.