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Rexinoid

Bexarotene for Breast Cancer

Phase 1
Waitlist Available
Led By Parijatham (Priya) S Thomas
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 15, and day 28 visits
Awards & highlights

Study Summary

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

Eligible Conditions
  • Breast Cancer
  • Atypical Ductal Hyperplasia
  • Atypical Lobular Hyperplasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 15, and day 28 visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 15, and day 28 visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Incidence of Adverse Events (Dose Limiting Toxicities)
Secondary outcome measures
Number of Participants With Bexarotene Concentration in Tissue
Number of Participants With Changes in Markers of Systemic Toxicity
Number of Participants With Trace Level of Bexarotene Concentration in Plasma Detected
Other outcome measures
Tissue Markers

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (bexarotene)Experimental Treatment2 Interventions
Group 1 will apply 10mg bexarotene topically to one breast QOD for 4 weeks; Group 2 will apply 10mg bexarotene topically to one breast QOD for 1 week and then daily for 3 weeks after confirmation that toxicity is at an acceptable range; Group 3 will apply 10mg bexarotene topically to one breast QOD for 1 week, then daily for 1 week, and then 20mg daily for 2 weeks after confirmation that toxicity is at an acceptable range.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bexarotene
2014
Completed Phase 4
~320

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,465 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Parijatham (Priya) S ThomasPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer
2018. "Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03323658.
~4 spots leftby Apr 2025
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