Calendario›SNY›epidoxorubicine
epidoxorubicine
Study of Docetaxel in Breast Cancer Patients
Ensayo de Sanofi en Cancer de mama.
Más ensayos de: Cáncer de mama.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 998
- Centros
- 1
- Fin del objetivo primario
- dic 2007
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en dic 1997.
Qué mide
Invasive Disease-Free Survival (IDFS) - with exclusion of ductal carcinoma in situ- DCIS- either collateral or ipsilateral, according to STEEP in adjuvant breast cancer trial: Standardized Definitions for Efficacy Endpoints (Time between randomization date and date of local or distant recurrence or contralateral breast cancer or second primary (non breast) cancer or death from any cause, whichever occurs first) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary objectives: * To compare the disease free survival (DFS) in patients treated with the sequential epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin Secondary objectives: * To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and CMF (only patients with \> or = 4 lymph nodes) regimen to that in patients treated with sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen * To evaluate the overall survival in each arm * To evaluate the tolerability of a sequential intensified epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C) * To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen versus a standard sequential epidoxorubicin/CMF regimen (arm A)
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| 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 (NCT00174707), actualizada en dic 2009.