A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00688740Tipo: INTERVENTIONALInicio: 1 de jun de 1997Fin estimado: 1 de ene de 2010

Traducción no disponible, mostrando original

Resumen

The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.

Descripción detallada

In addition to the 5-year analysis conducted in September 2003, two other analyses were planned when 590 and 700 Disease Free Survival events occurred. However, due to the lower than predicted DFS event rate, and in agreement with FDA and EMA, a time-based final analysis at 10 years was considered more appropriate than an event-based (700 Disease Free Survival events) analysis.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: FEMALE

Criterios de inclusión

Histologically proven breast cancer (invasive adenocarcinoma with at least one axillary lymph node showing evidence of tumor among a minimum of six resected lymph nodes).
Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer. Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma.

Criterios de exclusión

Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.

Intervenciones

drug

Docetaxel

intravenous

drug

5-fluorouracil

intravenous

drug

Doxorubicin

intravenous

drug

Cyclophosphamide

intravenous

Ubicaciones

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi

ColaboradorCancer International Research Group (CIRG)

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