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Statins for Breast Cancer

Phase 2
Recruiting
Led By Mridula George, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patients must agree to use effective barrier contraception during the period of therapy
Adequate renal function: Creatinine < 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five years
Awards & highlights

Study Summary

This trial suggests that adding statins could reduce heart damage in breast cancer patients receiving anti-HER2 therapy.

Who is the study for?
This trial is for women over 18 with Stage I-III HER2 positive breast cancer who haven't had HER2 therapy or anthracycline chemo before. They must have good heart, liver, and kidney function, no recent major surgery or significant diseases that could affect the study's safety. Participants can't be on statins already, have stage IV cancer, uncontrolled blood pressure, active liver disease or certain infections.Check my eligibility
What is being tested?
The trial tests if Lipitor (40mg tablet) reduces treatment delays/discontinuations due to heart damage in patients receiving anti-HER2 therapy for early-stage breast cancer. It aims to see if adding a statin can protect the heart during such treatments.See study design
What are the potential side effects?
While not specified here, common side effects of Lipitor may include muscle pain/weakness, digestive problems like diarrhea or constipation, and possible liver issues which will be monitored closely given the patient population.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control during my treatment.
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My kidney function is within the required range.
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I have been diagnosed with Stage I-III breast cancer.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.
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I have never been treated with HER2 targeted therapy or anthracycline-based chemotherapy.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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My liver tests are within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and five 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
Number of Participants With at Least One Adverse Event will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years
Secondary outcome measures
Pain
Other outcome measures
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure emotional distress
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure fatigue
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure physical functioning
+1 more

Side effects data

From 2013 Phase 3 trial • 59 Patients • NCT01004406
14%
Chest pain
14%
Sinusitis
10%
Musculoskeletal pain
10%
Otitis externa
5%
Angina unstable
5%
Abdominal discomfort
5%
Tachycardia
5%
Sinus bradycardia
5%
Hypertension
5%
Cholecystitis acute
5%
Catheter site haemorrhage
5%
Medical device complication
5%
Coronary artery disease
5%
Hypertensive crisis
5%
Ischaemic cardiomyopathy
5%
Atrial fibrillation
5%
Dizziness
5%
Leukocytosis
5%
Gallbladder disorder
5%
Headache
5%
Bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intensive LDL-lowering Therapy (ILLT)
Standard Statin Monotherapy (SMT)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Anti-HER2 targeted therapy + Lipitor 40mg dailyExperimental Treatment1 Intervention
Participants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy.

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
431 Previous Clinical Trials
64,598 Total Patients Enrolled
Mridula George, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

Anti-HER2 targeted therapy + Lipitor 40mg daily Clinical Trial Eligibility Overview. Trial Name: NCT05559164 — Phase 2
Cardiac Toxicity Research Study Groups: Anti-HER2 targeted therapy + Lipitor 40mg daily
Cardiac Toxicity Clinical Trial 2023: Anti-HER2 targeted therapy + Lipitor 40mg daily Highlights & Side Effects. Trial Name: NCT05559164 — Phase 2
Anti-HER2 targeted therapy + Lipitor 40mg daily 2023 Treatment Timeline for Medical Study. Trial Name: NCT05559164 — Phase 2
~33 spots leftby Sep 2026
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