NCT05941520View on ClinicalTrials.gov

Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 23, 2024

Primary Completion Date

August 23, 2027

Study Completion Date

September 1, 2028

Conditions
Breast Atypical HyperplasiaBreast CarcinomaBreast Ductal Carcinoma In SituBreast Lobular Carcinoma In Situ
Interventions
DRUG

Acolbifene Hydrochloride

Given PO

PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Mammography

Undergo 3D mammography

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Random Periareolar Fine-Needle Aspiration

Undergo RPFNA

DRUG

Tamoxifen

Given PO

Trial Locations (4)

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

60611

RECRUITING

Northwestern University, Chicago

66160

RECRUITING

University of Kansas Cancer Center, Kansas City

91010

NOT_YET_RECRUITING

City of Hope Comprehensive Cancer Center, Duarte

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH