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Afimoxifene in Reducing the Risk of Breast Cancer in Women With Mammographically Dense Breast

NCT03063619 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2024-02-22

Study results available
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Summary

This randomized phase II trial studies how well afimoxifene works in reducing the risk of breast cancer in women with mammographically dense breast. Estrogen can cause the growth of breast cancer cells. Hormone therapy using afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.

Conditions

  • Mammographically Dense Breast

Interventions

DRUG

Afimoxifene

Applied topically

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo

Applied topically

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Banu Arun, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2021-10-26
Completion
2021-10-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063619 on ClinicalTrials.gov