Calendario›SNY›Doxorubicin
Doxorubicin
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Ensayo de Sanofi en Cancer de mama.
Más ensayos de: Cáncer de mama.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 3.222
- Centros
- 42
- Fin del objetivo primario
- dic 2014
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en abr 2001.
Qué mide
Percentage of Participants With Disease Free Survival at 5 Years (From randomization until relapse or death or up to 5 years) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary objective: * Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin. Secondary objective: * Compare overall survival of participants treated with these regimens. * Compare the toxic effects (including cardiac) of these regimens in these participants. * Compare quality of life of participants treated with these regimens. * Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants. * For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens.
Más ensayos de SNY
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| Avalglucosidase alfa · Mini-COMET | Fase 2 | En marcha, sin reclutar | sep 2019 (real) |
| Yellow fever vaccine | Fase 2 | En marcha, sin reclutar | may 2022 (real) |
| Yellow fever vaccine · VYF02 | Fase 2 | En marcha, sin reclutar | jun 2022 (real) |
| SAR441344 IV | Fase 2 | En marcha, sin reclutar | sep 2022 (real) |
| Meningococcal Polysaccharide | Fase 3 | En marcha, sin reclutar | mar 2023 (real) |
| Isatuximab IV · IRAKLIA | Fase 3 | En marcha, sin reclutar | nov 2024 (real) |
Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00021255), actualizada en sep 2016.