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HMG-CoA Reductase Inhibitor

Atorvastatin for Breast Cancer

Phase 2
Waitlist Available
Led By Carlos H Barcenas
Research Sponsored by M.D. Anderson Cancer Center
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 at 2 years
Awards & highlights

Study Summary

This trial looks at how well atorvastatin works in treating patients with TNBC who didn't have all signs of cancer removed after upfront chemotherapy.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportions of patients with undetectable circulating tumor cells (CTC)
Secondary outcome measures
Baseline C-reactive protein (CRP) and/or change in serum lipid levels
Baseline absolute number of circulating tumor cells (CTCs) and/or CTC change
Baseline fasting lipid profile level (low density lipoprotein cholesterol [LDL-C]) and/or change in serum lipid levels
+3 more

Side effects data

From 2014 Phase 3 trial • 58 Patients • NCT02084069
3%
Postoperative bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Control

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (atorvastatin)Experimental Treatment1 Intervention
Patients receive standard of care atorvastatin PO QD for up to 24 months.
Group II: Group II (capecitabine)Active Control1 Intervention
Patients not eligible to receive atorvastatin, will be enrolled into non-statin observation group with/without capecitabine treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
1998
Completed Phase 4
~10900

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,661 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,796 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Carlos H BarcenasPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Atorvastatin (HMG-CoA Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03872388 — Phase 2
Breast Cancer Research Study Groups: Group II (capecitabine), Group I (atorvastatin)
Breast Cancer Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT03872388 — Phase 2
Atorvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03872388 — Phase 2

Frequently Asked Questions

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

Has Atorvastatin been officially sanctioned by the FDA?

"Due to the Phase 2 designation of this medication, atorvastatin is estimated to have a safety rating of two on our three-point scale. This reflects the fact that there is some evidence pointing towards its security but no data which supports efficacy."

Answered by AI

How many individuals are eligible to participate in this research endeavor?

"A total of 80 candidates, who comply with the outlined requirements, are necessary to complete this trial. Eligible participants can enrol at M D Anderson Cancer Center in Houston or Banner - MD Anderson Cancer Center -Northern Colorado located in Greeley."

Answered by AI

What conditions or ailments might Atorvastatin be employed to treat?

"Atorvastatin is usually prescribed to regulate lipid levels in the body, but has also been linked to improved outcomes for patients with coronary artery disease (CAD), refractory ovarian cancer, and coronary artery thrombosis."

Answered by AI

Could you please provide details on the current enrollment period for this research?

"Affirmative. Clinicaltrials.gov indicates that this medical trial is presently enrolling patients, with the initial post dated January 14th 2019 and last update on April 5th 2022. A total of 80 people are being sought at five different clinical sites."

Answered by AI

How has Atorvastatin been tested in other clinical experiments?

"The first exploration of atorvastatin took place in 2005 at the Vermont Cancer Center. Subsequently, 1021 trials were completed and 403 are currently being conducted around the world - most notably out of Houston, Texas."

Answered by AI

At what number of locations are participants being administered this trial?

"There are 5 medical centres currently recruiting for this trial, including the M D Anderson Cancer Center in Houston, Banner - MD Anderson Cancer Centre - Northern Colorado in Greeley, and Cooper Hospital University Medical Centre in Camden."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy
2019. "Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03872388.
~1 spots leftby Apr 2025
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