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Letrozole and Ovarian Suppression in Premenopausal Metastatic Breast Cancer
NCT00498901Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2007
- Primary completion
- Dec 2007
- Countries
- 1
- Sponsor
- University of Washington
- Modality
- Orthosteric Ligands
- Drugs
- letrozole
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of letrozole in breast cancer, sponsored by University of Washington. Primary endpoint: Overall Response Rate. Started Feb 2007; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Letrozole + OS
Letrozole combined with Ovarian Suppression (Medical or Surgical)
03
Who it enrols
Premenopausal women with histologically confirmed ER/PR-positive metastatic (Stage IV) breast cancer. Patients must have measurable disease and no rapidly progressing visceral involvement.
04
Endpoints
Primary
Overall Response Rate
Secondary
Time to Treatment Failure
Time to Progression
Overall Survival
Clinical Benefit Rate
Toxicity
Disease-Free Survival
Adequacy of Estrogen Suppression
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