USO 25021
C4551002: ISANG INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 3 STUDY NG PF-07248144 PLUS FULVESTRANT NA INIHAHAMBING SA PINILI NG IMBESTIGATOR NA THERAPY SA MGA MATATANDA NA KALAhok NA MAY HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER NA ANG SAKIT AY UMULONG PAGKATAPOS NG NAUNANG CDK4/6 INHIBITOR-BASED THERAPY
Mga Uri ng Sakit: Pananaliksik sa Kanser sa Suso
Mga Kinakailangan sa Kwalipikasyon:
• HR+ /HER2-negative (IHC 0/1+, IHC 2+ & ISH-) LA/met BC
• Must have had prior CDK4/6i + ET (adv/met setting) OR adjuvant CDK4/6i + ET
with documented PD/recurrence <12 months after last dose of CDK4/6i
• Must have had 1 prior systemic tx:
• ET monotherapy in adv/met OR
• Rechallenge tx with CDK4/6i + ET adv/met OR
• Targeted therapy for ESR1 or BRCA1/2
• Prior fulvestrant/exemestane is allowed but not required
• Prior chemo, including ADCs, in adv/met setting are excluded
• >2 prior lines of systemic tx in adv/met setting are excluded
• Measurable disease or bone only disease by RECIST v1.1
• Tissue alterations in PIK3CA/AKT1/PTEN (local F1CDx assay) are excluded
• Prior target tx for 1 or more of these alterations are excluded
• FFPE tumor tissue must be provided
• Known active uncontrolled or symptomatic CNS
metastases, carcinomatous meningitis or
leptomeningeal disease excluded
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