NCT03323658

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

A Phase I Dose Escalation Study of Topical Bexarotene in Women at High Risk for Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the recommended phase II dose of topical bexarotene 1% (weight by weight \[w/w\]) gel for evaluation in healthy women. (Dose Escalation Group) II. Conduct an intervention of topical 1% bexarotene gel to an unaffected breast of healthy women at high risk for breast cancer for 4 weeks at the maximum tolerated dose (MTD) as determined during the dose escalation group phase to assess bexarotene concentration in the breast tissue. (Dose Expansion Group) SECONDARY OBJECTIVES: I. To detect bexarotene concentration in the serum at baseline and at 4 weeks of treatment. II. To detect bexarotene concentration in the breast tissue at 4 weeks of treatment in the dose escalation group. III. To investigate the effects of topical bexarotene on serum biomarkers, we will determine the change from baseline in i) lipid biomarkers (total cholesterol, triglycerides, low density lipoprotein \[LDL\], high density lipoprotein \[HDL\]), ii) thyroid function biomarkers (thyroid stimulating hormone \[TSH\], T4, T3), iii) calcium. EXPLORATORY OBJECTIVE: I. To examine changes in gene expression associated with retinoid action. (Dose Expansion Group) OUTLINE: This is a dose-escalation study. Group 1 will apply 10mg bexarotene topically to one breast every other day (QOD) for 4 weeks; Group 2 will apply 10mg bexarotene topically to one breast every other day (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 every other day (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. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Breast Atypical Ductal Hyperplasia
• Breast Atypical Lobular Hyperplasia
• Breast Ductal Carcinoma In Situ
• Breast Lobular Carcinoma In Situ
• Invasive Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Bexarotene	Given topically
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-06-15
• Primary completion: 2021-08-03
• Completion: 2022-03-25
• First posted: 2017-10-27
• Last updated: 2023-01-10
• Results posted: 2022-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study