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NCT03317405 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery
A Phase 1 study of Breast Ductal Carcinoma In Situ and Stage II Breast Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 3
- Study locations
NCT03317405: Active Phase 1 study of Breast Ductal Carcinoma In Situ and Stage II Breast Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
NCT03317405 is a Phase 1 study of Breast Ductal Carcinoma In Situ and Stage II Breast Cancer AJCC v6 and v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 32 participants, below the 2,286-participant average among 15 other Breast Ductal Carcinoma In Situ trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03317405, a Phase 1 study of Breast Ductal Carcinoma In Situ and Stage II Breast Cancer AJCC v6 and v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Number of participants with dermal toxicity on breast skin at the transdermal gel application site. Will be assessed by Common Terminology Criteria for Adverse Events version 4.
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- DRUG Endoxifen Hydrochloride
- OTHER Placebo Administration
Study Locations (3)
California
- Cedars Sinai Medical Center - Los Angeles
Illinois
- Northwestern University - Chicago
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-10-31 |
| Est. Completion | 2026-08-12 |
| Phase | Phase 1 |
What the registry record for NCT03317405 still lists
NCT03317405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 2,286-participant average among 15 other Breast Ductal Carcinoma In Situ trials with a reported enrollment target (99% lower).
The record links to 10 conditions, with Breast Ductal Carcinoma In Situ appearing as the primary indexed condition, and to 3 interventions - of which Questionnaire Administration is the first listed.
NCT03317405 reports a single indexed study location in California, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT03317405 about?
NCT03317405 is a clinical study titled "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 endoxifen hydrochloride in treating participants who are undergoing breast surgery. Endoxifen hydrochloride may treat or reduce the risk of breast cancer.
What is the current status of trial NCT03317405?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-10-31. Estimated completion is 2026-08-12.
What conditions does trial NCT03317405 study?
This clinical trial studies the following conditions: Breast Ductal Carcinoma In Situ, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7.
What interventions are being tested in trial NCT03317405?
The interventions under investigation include: Questionnaire Administration (OTHER), Endoxifen Hydrochloride (DRUG), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT03317405?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03317405 being conducted?
This trial has 3 study locations across California, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Ductal Carcinoma In Situ
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03317405's enrollment target sits among peer trials
32 16th of 15 the lowest of 15 other Breast Ductal Carcinoma In Situ trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Ductal Carcinoma In Situ trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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