Resumen del Estudio
Este estudio de investigación clínica busca mejorar el tratamiento para pacientes con cáncer de mama en etapa temprana pero clasificados como de 'alto riesgo' de recurrencia. Se enfoca específicamente en dos tipos de cáncer: el Triple Negativo (TNBC) y el cáncer con receptores hormonales bajos y HER2 negativo (HR-bajo+/HER2-). El objetivo es combatir la enfermedad antes de que se extienda o regrese. Los investigadores están evaluando un medicamento llamado Sacituzumab tirumotecan (Sac-TMT), una terapia dirigida diseñada para atacar células cancerosas específicas. El estudio comparará si la combinación de Sac-TMT junto con inmunoterapia (pembrolizumab) y quimioterapia es más efectiva que el tratamiento estándar actual. Se busca lograr una mayor eliminación del tumor antes de la cirugía y aumentar el tiempo de vida sin enfermedad a largo plazo.
Criterios de Elegibilidad
Resumen de Elegibilidad:Criterios de inclusión: Pacientes con cáncer de mama temprano de alto riesgo (TNBC o HR-bajo+/HER2-) sin tratamiento previo, con función orgánica adecuada y aptos para cirugía. Criterios de exclusión: Cáncer metastásico (Etapa IV), tratamientos oncológicos previos, historial de enfermedades autoinmunes severas o neumonitis.
- Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the investigator based on radiological and/or clinical assessment:
- cT1c, N1-N2
- cT2, N0-N2
- cT3, N0-N2
- cT4a-d, N0-N2
- The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2-), as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
- Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before treatment randomization.
- Demonstrates adequate organ function.
- Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
- Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
- Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).
- Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
- Received prior treatment with a topoisomerase I inhibitor-containing ADC.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Known additional malignancy that is progressing or has required active treatment within the past 5 years.
- Uncontrolled systemic disease.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.