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New drug acolbifene takes on tamoxifen in breast cancer prevention trial

NCT ID NCT05941520

Recruiting now Prevention Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 08, 2026 · Updated 4 times

Summary

This study tests whether acolbifene or a low dose of tamoxifen can reduce breast cancer risk in premenopausal women at high risk. Both drugs block estrogen from reaching breast cells. Researchers will measure changes in breast tissue, blood, and mammograms over six months in 80 women.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
acolbifene and tamoxifen
What this could lead to
If successful, this could point toward a new prevention option for breast cancer in high-risk premenopausal women, potentially with fewer side effects than standard tamoxifen.
What could go wrong
This is a small Phase 2 trial with only 80 participants, so results may not apply to all women. The study measures biological markers, not actual cancer rates, so it's unclear if these changes lead to fewer cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

atypical lobular breast hyperplasia breast carcinoma breast carcinoma in situ breast neoplasm ductal breast carcinoma in situ lobular breast carcinoma in situ breast cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST ATYPICAL HYPERPLASIA BREAST CARCINOMA BREAST DUCTAL CARCINOMA IN SITU BREAST LOBULAR CARCINOMA IN SITU

Contacts and locations

Locations

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

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