Trial NCT03317405

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

This randomized phase I trial studies the side effects and best dose of Z-endoxifen
hydrochloride in treating participants who are undergoing breast surgery. Z-endoxifen
hydrochloride may treat or reduce the risk of breast cancer.

Intervention

Laboratory Biomarker Analysis, Pharmacological Study, Placebo, Questionnaire Administration, Z-Endoxifen Hydrochloride

Condition

BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ductal Breast Carcinoma In Situ, Lobular Breast Carcinoma In Situ, Prophylactic Mastectomy Patient, Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7

Investigators

Melissa L. Pilewskie, Seema A. Khan, Scott R. Karlan

See list of participating sites