Resumen del Estudio
Los investigadores están buscando formas nuevas y más efectivas de tratar el cáncer de mama triple negativo (CMTN) y el cáncer de mama con receptores hormonales bajos/HER2 negativo. Entendemos lo difícil que es enfrentar este diagnóstico, por lo que el objetivo es mejorar las opciones disponibles antes de la intervención quirúrgica. El propósito principal de este estudio es evaluar la seguridad y tolerancia de estos tratamientos. Específicamente, queremos averiguar si los pacientes que reciben patritumab deruxtecán, pembrolizumab y quimioterapia antes de su cirugía logran llegar al quirófano con menos células cancerosas, en comparación con quienes reciben el tratamiento estándar actual de pembrolizumab combinado con quimioterapia.
Criterios de Elegibilidad
Resumen de Elegibilidad:Pueden participar: Pacientes con diagnóstico confirmado de cáncer de mama localmente avanzado (triple negativo o HER2 negativo con receptores hormonales bajos) que no se haya diseminado a otras partes del cuerpo, con buena función cardíaca y estado de salud general adecuado. No pueden participar: Personas que ya hayan recibido cualquier tratamiento previo para el cáncer de mama actual (incluyendo radiación o cirugía), con enfermedades cardiovasculares graves, metástasis conocidas o antecedentes de enfermedad pulmonar intersticial severa.
- Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2
- Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation/randomization
- Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan
- Has uncontrolled or significant cardiovascular disease before randomization
- Has clinically significant corneal disease
- Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease
- Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
- Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)
- Has metastatic (Stage IV) breast cancer or cN3 nodal involvement
- Has known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, or where suspected ILD/pneumonitis cannot be ruled out by standard diagnostic assessments
- Has an active infection requiring systemic therapy
- Has concurrent active HBV and HCV infection
- Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness