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

Major Program
Phase 0 I II Cancer Prevention Clinical Trials Program
Research Group
Breast and Gynecologic Cancer
Sponsor
National Cancer Institute (NCI)
Status
Active, not recruiting
NCT ID
NCT03317405
This randomized phase I trial studies the side effects and best dose of endoxifen hydrochloride in treating participants who are undergoing breast surgery. Endoxifen hydrochloride may treat or reduce the risk of breast cancer.
Intervention
Endoxifen Hydrochloride, Placebo Administration, Questionnaire Administration
Condition
Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, 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
Seema A Khan

See list of participating sites