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Selinexor in Metastatic TNBC
NCT02402764Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2015
- Primary completion
- Mar 2016
- Countries
- 1
- Sponsor
- Moffitt Cancer Center
- Modality
- Small Molecules
- Drugs
- selinexor
- Conditions
- triple-negative breast cancer (TNBC)
01
Overview
Phase 2, open-label, single-arm trial of selinexor in triple-negative breast cancer (TNBC), sponsored by Moffitt Cancer Center. Primary endpoint: Clinical Benefit Rate at 10 months. Started Jul 2015; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Selinexor Treatment
Participants receive Selinexor monotherapy.
03
Who it enrols
Patients with metastatic TNBC who have progressed on at least one prior chemotherapy regimen. Must have adequate organ function and BSA >= 1.4 m^2.
04
Endpoints
Primary
Clinical Benefit Rate
Secondary
Best Overall Response
Duration of Overall Response
Progression-Free Survival
Overall Survival
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