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Atorvastatin for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast CancerAtorvastatin - Drug
Eligibility
35 - 55
Female
What conditions do you have?
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Study Summary

This trial is testing whether the cholesterol-lowering medication atorvastatin can reduce the risk of breast cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 1 year

1 year
To correlate changes in breast density with changes in molecular markers.
To evaluate change in percent mammographic density after one year of statin administration in pre-menopausal women at high risk for breast cancer.
To evaluate changes in IGF1 levels after 12 months of statin administration in pre-menopausal women at high-risk for breast cancer.
To explore changes in breast duct cell cytology in a subset of patients after 12 months of statin administration in a subset of the trial population.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
Topiramate Tablets
1
CC-92328
2
Futibatinib

Side Effects for

Treatment
3%Postoperative bleeding
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT02084069) in the Treatment ARM group. Side effects include: Postoperative bleeding with 3%.

Trial Design

2 Treatment Groups

Atorvastatin
1 of 2
Sugar Pill
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Atorvastatin · Has Placebo Group · Phase 2

Atorvastatin
Drug
Experimental Group · 1 Intervention: Atorvastatin · Intervention Types: Drug
Sugar Pill
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

University of VermontLead Sponsor
254 Previous Clinical Trials
3,742,717 Total Patients Enrolled
9 Trials studying Breast Cancer
3,687,267 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
60 Previous Clinical Trials
135,327 Total Patients Enrolled
35 Trials studying Breast Cancer
128,388 Patients Enrolled for Breast Cancer
Cancer and Leukemia Group BNETWORK
80 Previous Clinical Trials
117,888 Total Patients Enrolled
19 Trials studying Breast Cancer
30,676 Patients Enrolled for Breast Cancer
Marie E Wood, MDPrincipal InvestigatorUniversity of Vermont

Eligibility Criteria

Age 35 - 55 · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are pre-menopausal women with regular menstrual cycles (4 cycles in the past 6 months).
You have had a biopsy demonstrating atypical hyperplasia or lobular neoplasia/LCIS.
You have a BRCA1/2 mutation.
You have one first degree relative and two or more second or third degree relatives with breast cancer.
References

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