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NCT06195306 · ClinicalTrials.gov registry record · Phase 2
Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction
A Phase 2 study of Breast Carcinoma and Breast Ductal Carcinoma In Situ, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 3
- Study locations
NCT06195306 is a Phase 2 study of Breast Carcinoma and Breast Ductal Carcinoma In Situ that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06195306, a Phase 2 study of Breast Carcinoma and Breast Ductal Carcinoma In Situ, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen is approved by the Food and Drug Administration for prevention of breast cancer in women at increased risk. Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver. Omega-3 fatty acids may work to prevent cancer in overweight or obese individuals. Tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal, overweight or obese, and at increased risk.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- PROCEDURE Mammography
- DRUG Omega-3-Acid Ethyl Esters
- PROCEDURE Random Periareolar Fine-Needle Aspiration
Study Locations (3)
Kansas
- University of Kansas Cancer Center - Kansas City
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2025-07-28 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06195306
The ClinicalTrials.gov registry entry for NCT06195306 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (91% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06195306 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Kansas, Michigan, Ohio.
Frequently Asked Questions
What is clinical trial NCT06195306 about?
NCT06195306 is a clinical study titled "Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction". This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the ef...
What is the current status of trial NCT06195306?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2025-07-28. Estimated completion is 2028-01-01.
What conditions does trial NCT06195306 study?
This clinical trial studies the following conditions: Breast Carcinoma, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, Breast Atypical Hyperplasia.
What interventions are being tested in trial NCT06195306?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Mammography (PROCEDURE), Omega-3-Acid Ethyl Esters (DRUG), Random Periareolar Fine-Needle Aspiration (PROCEDURE).
Who is sponsoring clinical trial NCT06195306?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06195306 being conducted?
This trial has 3 study locations across Kansas, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.