Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

October 31, 2018

Primary Completion Date

February 22, 2021

Study Completion Date

August 12, 2026

Conditions
Breast Ductal Carcinoma In SituBreast Lobular Carcinoma In SituStage 0 Breast Cancer AJCC v6 and v7Stage I Breast Cancer AJCC v7Stage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage II Breast Cancer AJCC v6 and v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Stage III Breast Cancer AJCC v7Stage IIIA Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7
Interventions
DRUG

Endoxifen Hydrochloride

Apply to the skin

OTHER

Placebo Administration

Apply to the skin

OTHER

Questionnaire Administration

Ancillary studies

Trial Locations (3)

10065

Memorial Sloan Kettering Cancer Center, New York

60611

Northwestern University, Chicago

90048

Cedars Sinai Medical Center, Los Angeles

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH