Cáncer de Mama HER2+
Estado: ReclutandoEstudio de fase IIIb, multinacional, multicéntrico, aleatorizado, de etiqueta abierta para evaluar la preferencia de los pacientes por la administración domiciliaria de una combinación en dosis fijas de Pertuzumab y Trastuzumab para la administración subcutánea en participantes con Cáncer de Mama HER2+ en estado temprano o localmente avanzado/inflamatorio.
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Principales Criterios de Inclusión:
- Female and male participants with stage II-IIIC early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer
- Primary tumor >2 centimetres (cm) in diameter, or node-positive disease
HER2+ breast cancer confirmed by a local laboratory prior to study enrollment. HER2+ status will be determined based on pretreatment breast biopsy material and defined as 3+ by Immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2018 and updates (Wolff et al. Arch Pathol Lab Med 2018) - Hormone receptor status of the primary tumor determined by local assessment following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and updates (Allison et al. J Clin Oncol 2020)
- Agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy, including the axillary nodes
- Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for local confirmation of HER2 and hormone receptor status following current ASCO/CAP guidelines
- Laboratorio:ROCHE
- Área Terapéutica:Oncología
- Fase del estudio:IIIb
- Código de Estudio:MO43110
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- ICEGCLINIC
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