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

Major Program(s) or Research Group(s)

  • Breast and Gynecologic Cancer
  • Phase 0/I/II Cancer Prevention Clinical Trials Program

Sponsor

National Cancer Institute (NCI)

Status

Recruiting

ClinicalTrials.gov ID

For more information, see ClinicalTrials.gov NCT03317405

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

Questionnaire Administration, Z-Endoxifen Hydrochloride, Placebo 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, Scott R. Karlan, Seema A. Khan, Melissa L. Pilewskie

See list of participating sites