Status:
COMPLETED
Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Sanofi
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief 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 s...
Detailed Description
Primary objective: * To compare disease-free survival (DFS) after treatment with docetaxel in combination with doxorubicin and cyclophosphamide (TAC) to 5-Fluorouracil in combination with doxorubicin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2013
Estimated Enrollment :
1060 Patients enrolled
Trial Details
Trial ID
NCT00121992
Start Date
July 1 1999
End Date
March 6 2013
Last Update
April 4 2023
Active Locations (1)
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1
Spanish Breast Cancer Research Group
San Sebastián de los Reyes, Madrid, Spain, 28700