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CÁNCER DE MAMA

El Período de Tratamiento consta de las siguientes fases:

*Fase Neoadyuvante (Prequirúrgica): máximo de 8 ciclos

Ciclos 1 a 4 de paclitaxel (PTX) (1 ciclo = cada 3 semanas [Q3W]): nivolumab o placebo de nivolumab + paclitaxel semanalmente.

Seguido de ciclos 1 a 4 de antraciclina-ciclofosfamida (AC) (1 ciclo = cada 2 semanas [Q2W] o Q3W [la frecuencia de la dosis la determinará el Investigador]): nivolumab o placebo de nivolumab + AC

 

Cirugía

*Fase Adyuvante (Posquirúrgica): máximo de 7 ciclos. Ciclos 1 a 7 adyuvantes (1 ciclo = cada 4 semanas [Q4W]): nivolumab o placebo de nivolumab + ET.

MK-3475-756 (MSD)

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CA2097FL

CRITERIOS DE INCLUSIÓN

- Carcinoma ductal de mama invasivo localizado, confirmado por el patólogo local, que incluye T1c-T2 (tamaño del tumor ≥ 2 cm), estadio ganglionar clínico (cN) 1-cN2 o T3-T4, cN0-cN2. El estado ganglionar debe ser confirmado citológicamente. Nota: Se permite el BC inflamatorio.

-Los participantes deben tener BC ER+, HER2-

-Los participantes deben considerarse elegibles para quimioterapia neoadyuvante. 

-Los participantes deben considerarse elegibles para cirugía y deben aceptar someterse a cirugía después de completar la terapia neoadyuvante.

-Los participantes deben aceptar proporcionar tejido de tumor de mama primario en condición basal.