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NCT06184750 · ClinicalTrials.gov registry record · Phase 2
Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial
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
- 200
- Enrollment target
- 11
- Study locations
NCT06184750: Recruiting Phase 2 study of Breast Carcinoma and Breast Ductal Carcinoma In Situ, sponsored by National Cancer Institute (NCI).
NCT06184750 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 200 participants, below the 769-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (74% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06184750, 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
- 200 participants
- Enrollment target
- 11
- Study locations
Study Summary
This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.
Primary Outcome
Tamoxifen response is defined as absolute dense area reduction (aDAR) of \>= 10% on mammogram compared to baseline mammogram. A one sample exact binomial test for one proportion will be used, and the exact two-sided p-value will be reported. Response rate for the entire study population, as well as for the group of women who were dose-escalated, will be estimated and reported with the corresponding 95% confidence interval. Absolute and relative changes in dense area will be estimated using descr
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- OTHER Questionnaire Administration
- DRUG Tamoxifen
- PROCEDURE Mammography
Study Locations (11)
Illinois
- Northwestern University - Chicago
- University of Illinois College of Medicine - Chicago - Chicago
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Arizona
- University of Arizona Cancer Center - Prevention Research Clinic - Tucson
Kansas
- University of Kansas Cancer Center - Kansas City
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Missouri
- Washington University School of Medicine - St Louis
Ohio
- Case Western Reserve University - Cleveland
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-09-27 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 2 |
What NCT06184750 shows while recruiting
NCT06184750 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 769-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (74% lower).
The record links to 6 conditions, with Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06184750 lists 11 locations in 9 states (Illinois, Massachusetts, Arizona).
Frequently Asked Questions
What is clinical trial NCT06184750 about?
NCT06184750 is a clinical study titled "Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial". This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works b...
What is the current status of trial NCT06184750?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2024-09-27. Estimated completion is 2028-09-30.
What conditions does trial NCT06184750 study?
This clinical trial studies the following conditions: Breast Carcinoma, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, Estrogen Receptor-Positive Breast Carcinoma, Breast Atypical Ductal Hyperplasia.
What interventions are being tested in trial NCT06184750?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Questionnaire Administration (OTHER), Tamoxifen (DRUG), Mammography (PROCEDURE).
Who is sponsoring clinical trial NCT06184750?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06184750 being conducted?
This trial has 11 study locations across Arizona, Illinois, Kansas, Massachusetts, Michigan. 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 NCT06184750's enrollment target sits among peer trials
200 39th of 106 higher than 66 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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