Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-02-12 @ 12:57 AM
Study NCT ID:
NCT02295059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2014-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Omega-3 Fatty Acids and ERPR(-) and HER-2/Neu(+/-) Breast Cancer Prevention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to determine biological changes associated with a low vs high dose of omega 3 fatty acids, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), over 12 months in women at risk for recurrent breast cancer. The objectives of the trial are to develop mammary epithelial, adipose tissue specific markers of exposure and response to omega 3 fatty acid supplements that can be carried forward into definitive intervention trials of omega 3 fatty acids for breast cancer prevention. The investigators will randomize 80 subjects with hormone receptor negative, HER-2/neu overexpression positive or negative breast cancer to either a high or low dose of omega 3 fatty acids. Using fine needle aspiration to procure cellular samples of breast epithelial and adipose tissue, the investigators will determine the effects of omega 3 fatty acids on mammary specific biomarkers of response.
Detailed Description:
The study aims to determine biological changes that occur with a 12 month intervention of low (\~0.9 g EPA+DHA/day) vs high dose (\~5.4 g EPA+DHA/day) of omega 3 polyunsaturated fatty acids (PUFAs) in women survivors of hormone unresponsive breast cancer. The objectives of the trial are to develop unique mammary epithelial, adipose tissue specific markers of exposure and response to omega 3 fatty acid supplements that can be carried forward into definitive intervention trials of EPA, DHA/omega 3 PUFAs for breast cancer prevention. The investigators will randomize 80 subjects with hormone receptor negative, HER-2/neu overexpression positive or negative breast cancer to either a high or low dose of omega 3 PUFAs. Using fine needle aspiration to procure cellular samples of breast epithelial and adipose tissue, the investigators will determine the effects of omega 3 fatty acids on mammary specific biomarkers of response.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01CA164019-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |