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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: Recruiting Phase 2 study of Breast Carcinoma and Breast Ductal Carcinoma In Situ, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An analysis for difference between the two arms will be conducted to document a beneficial effect of addition of high dose omega-3 fatty acids to low dose tamoxifen. Paired and unpaired t-tests will be used.
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 |
What NCT06195306 shows while recruiting
NCT06195306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06195306's enrollment target sits among peer trials
66 71st of 106 higher than 34 of 106 other Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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