Calendario›SNY›Doxorubicine + docetaxel…
Doxorubicine + docetaxel…
BIG 02/98 Docetaxel - Breast Cancer
Ensayo de Sanofi en Cancer de mama.
Más ensayos de: Cáncer de mama.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 2.887
- Centros
- 21
- Fin del objetivo primario
- sep 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en jun 1998.
Qué mide
DFS of docetaxel arms versus non toxanes arm (DFS: interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death for any cause whichever occurs first. (810 events or median 5 year follow-up whichever occurs first) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary objectives: * To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes. Secondary objectives: * To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes * To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes * To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus polychemotherapy). * To compare overall survival of treatment arms. * To compare toxicity of treatment arms. * To evaluate pathologic and molecular markers for predicting efficacy. * Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00174655), actualizada en nov 2011.