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NCT05941520 · ClinicalTrials.gov registry record · Phase 2
Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer
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
- 80
- Enrollment target
- 4
- Study locations
NCT05941520 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 80 participants, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT05941520, 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
- 80 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- PROCEDURE Mammography
- PROCEDURE Random Periareolar Fine-Needle Aspiration
- DRUG Acolbifene Hydrochloride
Study Locations (4)
California
- City of Hope Comprehensive Cancer Center - Duarte
Illinois
- Northwestern University - Chicago
Kansas
- University of Kansas Cancer Center - Kansas City
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-08-23 |
| Est. Completion | 2028-09-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05941520
The ClinicalTrials.gov registry entry for NCT05941520 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 80 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 (90% 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.
NCT05941520 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Illinois, Kansas.
Frequently Asked Questions
What is clinical trial NCT05941520 about?
NCT05941520 is a clinical study titled "Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer". This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging or...
What is the current status of trial NCT05941520?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-08-23. Estimated completion is 2028-09-01.
What conditions does trial NCT05941520 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 NCT05941520?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Mammography (PROCEDURE), Random Periareolar Fine-Needle Aspiration (PROCEDURE), Acolbifene Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05941520?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05941520 being conducted?
This trial has 4 study locations across California, Illinois, Kansas, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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