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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 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.

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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.

Conditions Studied

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 Stage IIB Breast Cancer AJCC v6 and v7 Stage IA Breast Cancer AJCC v7 Stage I Breast Cancer AJCC v7 Breast Lobular Carcinoma In Situ Stage 0 Breast Cancer AJCC v6 and v7

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

FieldValue
Enrollment Target 32 participants
Start Date 2018-10-31
Est. Completion 2026-08-12
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03317405

The ClinicalTrials.gov registry entry for NCT03317405 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,286-participant average among 15 other Breast Ductal Carcinoma In Situ trials with a reported enrollment target (99% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.