Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-03-01 @ 1:25 PM
Study NCT ID:
NCT03323658
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2017-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Dose Escalation Study of Topical Bexarotene in Women at High Risk for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-01960 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| N01-CN-2012-00034 | None | None | View | |
| 2017-0911 | OTHER | M D Anderson Cancer Center | View | |
| MDA2016-08-02 | OTHER | DCP | View | |
| N01CN00034 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |