NCT04570956View on ClinicalTrials.gov

Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Situ, or Increased Breast Cancer Risk

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

July 26, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Breast Atypical HyperplasiaBreast Lobular Carcinoma in SituBreast Atypical Lobular HyperplasiaBreast Carcinoma
Interventions
DRUG

Tamoxifen

Oral Tamoxifen 10 mg/day

DRUG

Topical 4-OHT( 4-hydroxytamoxifen)gel 4 mg/each breast/day

Topical 4-OHT (4-hydroxytamoxifen) gel 4 mg/each breast/day

DRUG

Placebo

placebo pill or placebo gel

OTHER

Questionnaire Administration

Ancillary studies

Trial Locations (3)

55905

Mayo Clinic, Rochester

60208

Northwestern University, Evanston

08103

MD Anderson Cancer center at Cooper, Camden

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Amy C. Degnim

OTHER