USO 24151
Elacestrant frente a la terapia endocrina estándar en mujeres y hombres con cáncer de mama precoz con ganglios positivos, receptor de estrógenos positivo, HER2 negativo y alto riesgo de recurrencia - Estudio global, multicéntrico, aleatorizado y abierto de fase 3 (ELEGANT)(STML-ELA-0422)
Tipos de enfermedades: Investigación sobre el cáncer de mama
Requisitos de elegibilidad:
• Women or men with confirmed ER-positive (≥10% by IHC), HER2-negative [IHC = 0
or 1, or (IHC = 2 and ISH-negative)] early stage resected BC without evidence of
recurrence or distant metastases
• Pts should be between 2 to 6 years from the date of curative surgical resection
• Pts should have received ≥24 mo and <60 mo of ET(AIs or tamoxifen) with/without a
CDK4/6i and with/without an LHRH agonist
• Pts who received prior CDK4/6i or PARP inhibitor must have already
completed or discontinued these treatments
• Pt must be considered candidate for additional 5 years of ET
• Pts considered at high risk of recurrence at initial staging
• ≥ 4 positive axillary lymph nodes or
• 1-3 positive axillary lymph nodes and
• Histologic grade 3 disease or
• Tumor size ≥ 5 cm.
• Male pts receiving AI or elacestrant must receive an LHRH agonist
Para más información sobre este juicio, HAGA CLIC AQUÍ.
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