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Lovaza for Breast Cancer Risk Biomarkers
NCT01252277Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2010
- Primary completion
- Apr 2013
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of eicosapentaenoic acid + docosahexaenoic acid in breast cancer. Primary endpoint: The Proportion of Subjects That Complete an Intervention of Lovaza 4 Grams Per Day at 6 months. Started Nov 2010; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Lovaza
Lovaza 4g daily for 6 months
03
Who it enrols
Premenopausal women aged 25-54 at increased risk for breast cancer (Gail risk >= 1.67%, family history, or prior atypia) with cytomorphologic evidence of hyperplasia with atypia (Masood score >= 14).
04
Endpoints
Primary
The Proportion of Subjects That Complete an Intervention of Lovaza 4 Grams Per Day
Secondary
Modulation of the Risk Biomarker Masood Score
Modulation of Ki-67 Expression
Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma
Change in Quality of Life
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