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NCT03323658 · ClinicalTrials.gov registry record · Phase 1

Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT03323658: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT03323658 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03323658, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of bexarotene in preventing breast cancer in patients at high risk for breast cancer. Bexarotene belongs to a class of drugs that are called rexinoids, and it may reduce the incidence of breast tumors.

Primary Outcome

Dose Limiting Toxicity (DLT) is defined as a grade 2 skin adverse event that persists for at least 6 days or any grade 3 or greater adverse event possibly, probably, or definitely related to the study drug. In addition, a DLT will be a grade 2 skin adverse event that recurs and persists for at least 3 days.

Interventions

  • OTHER Questionnaire Administration
  • DRUG Bexarotene

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2018-06-15
Est. Completion 2022-03-25
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT03323658 record still lists

NCT03323658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 2 interventions - of which Questionnaire Administration is the first listed.

NCT03323658 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03323658 about?

NCT03323658 is a clinical study titled "Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer". This phase I trial studies the side effects and best dose of bexarotene in preventing breast cancer in patients at high risk for breast cancer. Bexarotene belongs to a class of drugs that are called rexinoids, and it may reduce the incidence of breast tumors.

What is the current status of trial NCT03323658?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-06-15. Estimated completion is 2022-03-25.

What interventions are being tested in trial NCT03323658?

The interventions under investigation include: Questionnaire Administration (OTHER), Bexarotene (DRUG).

Who is sponsoring clinical trial NCT03323658?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03323658's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT03323658, the US trial registry maintained by the National Library of Medicine. NCT03323658 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.