Resumen del Estudio
Este estudio clínico de Fase 3 está diseñado para pacientes con cáncer de mama avanzado o metastásico que es positivo para receptores hormonales (HR+) y negativo para HER2. El objetivo principal es evaluar si un nuevo medicamento llamado Sacituzumab tirumotecan (un conjugado anticuerpo-fármaco), administrado solo o junto con la inmunoterapia Pembrolizumab, funciona mejor que la quimioterapia estándar. El estudio está dirigido a personas cuyo cáncer ha progresado a pesar de haber recibido tratamientos hormonales previos (incluyendo inhibidores de CDK4/6). Al comparar estas nuevas estrategias contra el tratamiento que elegiría habitualmente su médico, los investigadores buscan encontrar terapias que logren frenar el crecimiento del tumor por más tiempo y mejorar la calidad de vida de los pacientes.
Criterios de Elegibilidad
Resumen de Elegibilidad:Eligibles: Pacientes con cáncer de mama HR+/HER2- irresecable o metastásico que hayan progresado tras terapia endocrina (hormonal) combinada con un inhibidor CDK4/6. Deben ser candidatos a quimioterapia y tener buen estado general. No elegibles: Pacientes con crisis visceral sintomática inminente o que ya hayan recibido quimioterapia previa para la enfermedad metastásica.
- Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
- Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
- Is a chemotherapy candidate
- Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Has adequate organ function
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received 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 breast cancer amenable to treatment with curative intent
- Has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
- Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
- Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy