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Anti-diabetic drug
Metformin for Breast Cancer Prevention
Phase 2
Waitlist Available
Led By Sherry Chow, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
21-54 years of age
Elevated fasting glucose (≥100 mg/dL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, 12 months
Awards & highlights
Study Summary
This trial will study whether metformin, a medication used to control blood sugar, can also reduce the risk features for breast cancer in overweight or obese premenopausal women.
Eligible Conditions
- Breast Cancer Prevention
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Breast Density at 12 Months
Change in Breast Density at 6 Months
Secondary outcome measures
Change From Baseline in Body Weight at 6 and 12 Months
Change From Baseline in Serum IGF-1 to IGFBP-3 Ratio at 6 and 12 Months
Change From Baseline in Serum IGF-2 Levels at 6 and 12 Months
+4 moreOther outcome measures
Change From Baseline in Metabolomics Profile in Nipple Aspirate Fluid at 6 and 12 Months
Change From Baseline in Plasma Metabolomics Profile at 6 and 12 Months
Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.
Group II: PlaceboPlacebo Group1 Intervention
1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
511 Previous Clinical Trials
148,137 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,495 Total Patients Enrolled
Sherry Chow, PhDPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
100 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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