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Presurgical Lapatinib in Breast Cancer
NCT00343759Phase 2
Key facts
- Status
- Withdrawn
- Start
- Jun 2006
- Primary completion
- May 2009
- Countries
- 1
- Sponsor
- University of Pennsylvania
- Modality
- Small Molecules
- Drugs
- lapatinib
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of lapatinib in breast cancer, sponsored by University of Pennsylvania. Primary endpoint: Change in downstream effector levels in biologic responders to lapatinib. Planned start Jun 2006; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Lapatinib
Patients will take 14 days of Lapatinib prior to definitive surgery.
03
Who it enrols
Patients with T2-T3 invasive breast cancer, any receptor status, no prior therapy.
04
Endpoints
Primary
Change in downstream effector levels in biologic responders to lapatinib
Secondary
Biologic response rate defined by induction of apoptosis
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