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

> **NCT03317405** · PHASE1 · ACTIVE_NOT_RECRUITING · sponsor: **National Cancer Institute (NCI)** · enrollment: 32 (actual)

## Conditions studied

- 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

## Interventions

- **DRUG:** Endoxifen Hydrochloride
- **OTHER:** Placebo Administration
- **OTHER:** Questionnaire Administration

## Key facts

- **NCT ID:** NCT03317405
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2018-10-31
- **Primary completion:** 2021-02-22
- **Final completion:** 2026-08-12
- **Target enrollment:** 32 (ACTUAL)
- **Last updated:** 2026-05-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03317405

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03317405, "Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT03317405. Licensed CC0.

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