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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: Recruiting Phase 2 study of Breast Carcinoma and Breast Ductal Carcinoma In Situ, sponsored by National Cancer Institute (NCI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Will be assessed in benign breast tissue acquired by random periareolar fine-needle aspiration. Change over the intervention period is expressed as the ratio of the relative abundance values (6-month value: baseline value) and then this fold change value is log transformed (base 2) for analysis. For this variable, values of zero indicate no change in the relative abundance of AGR2; positive values indicate an increase in the relative abundance; and negative values a decrease in the relative abun

Conditions Studied

Breast Carcinoma Breast Ductal Carcinoma In Situ Breast Lobular Carcinoma In Situ Breast Atypical Hyperplasia

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

FieldValue
Enrollment Target 80 participants
Start Date 2024-08-23
Est. Completion 2028-09-01
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What NCT05941520 shows while recruiting

NCT05941520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (90% 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.

NCT05941520 reports a single indexed study location in 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.

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 NCT05941520's enrollment target sits among peer trials

80 67th of 106 higher than 39 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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More recruiting context for NCT05941520

Source: ClinicalTrials.gov NCT05941520, the US trial registry maintained by the National Library of Medicine. NCT05941520 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.