Clinical Trial: NCT03317405
Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | National Cancer Institute (NCI) |
| Information Provided By: | National Cancer Institute (NCI) |
| Last Update Posted: | 2026-09-02 |
Study Overview
Brief Summary
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.
Official Title
Phase I Trial of Endoxifen Gel Versus Placebo Gel in Women Undergoing Breast Surgery
Conditions
Breast Carcinoma In Situ, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, 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
Intervention / Treatment
- Drug: Endoxifen Hydrochloride
- Other: Placebo Administration
- Other: Questionnaire Administration
Other Study ID Numbers
- NCI-2017-01921
- NCI-2017-01921
- N01-CN-2012-00035
- NCI2017-09-01
- NWU2017-09-01
- N01CN00035
- P30CA060553
Start Date (Actual)
2018-10-31
Primary Completion Date (Actual)
2021-02-22
Study Completion Date (Estimated)
2027-08-12
Enrollment (Actual)
32
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | National Cancer Institute (NCI) |
| Information Provided By: | National Cancer Institute (NCI) |
| Last Update Posted: | 2026-09-02 |
Study Overview
Brief Summary
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.
Official Title
Phase I Trial of Endoxifen Gel Versus Placebo Gel in Women Undergoing Breast Surgery
Conditions
Breast Carcinoma In Situ, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, 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
Intervention / Treatment
- Drug: Endoxifen Hydrochloride
- Other: Placebo Administration
- Other: Questionnaire Administration
Other Study ID Numbers
- NCI-2017-01921
- NCI-2017-01921
- N01-CN-2012-00035
- NCI2017-09-01
- NWU2017-09-01
- N01CN00035
- P30CA060553
Start Date (Actual)
2018-10-31
Primary Completion Date (Actual)
2021-02-22
Study Completion Date (Estimated)
2027-08-12
Enrollment (Actual)
32
Study Type
Interventional
Phase
Phase 1