USO 26017
Isang Open-Label, Randomized, Multicenter Phase 3 Study na Nag-iimbestiga sa Bisa at Kaligtasan ng BGB-43395 Plus Letrozole kumpara sa CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole sa mga Pasyenteng may Advanced o Metastatic HR+/HER2- Breast Cancer na Hindi Nakatanggap ng Naunang Systemic Anticancer Treatment para sa Advanced o Metastatic Disease.
Mga Uri ng Sakit: Pananaliksik sa Kanser sa Suso
Mga Kinakailangan sa Kwalipikasyon:
• HR+/HER2-negative MBC (local testing)
• Archived FFPE tumor tissue submission required
• Must have measurable disease per RECIST v1.1. Bone-only disease
are eligible if BICR-confirmed evaluable with ≥ 1 lytic or mixed lyticblastic bone lesion (excluded: blastic-only metastases)
• Prior systemic tx in adv/met setting are excluded (except for <2 weeks
of NSAI monotherapy immediately preceding screening and
discontinued until study treatment initiation).
• Prior tx with ET ± CDK4/6i in the (neo)adjuvant setting with disease
recurrence <12 months after last dose of ET are excluded
• Prior tx selective CDK4 or CDK2 targeting agent, or any other
investigational anticancer drug in any setting are excluded
• Prior SERDs in adjuvant setting is allowed if disease recurrence
occurred >12 months after last dose of ET
• Untreated brain metastasis are excluded
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