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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

Must not have

Participant who has a history of allergy or hypersensitivity to any of the study drugs

Concurrent active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up five years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to one or more of the drugs used in this study.

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I currently have an active infection.

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I am currently taking medication that affects liver enzyme CYP 3A4.

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I have not fully recovered from a major surgery within the last 4 weeks.

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I have a history of lung conditions like interstitial lung disease or sarcoidosis.

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My breast cancer is at stage IV.

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I am currently taking statin medication.

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I do not have any active liver disease.

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I have mild or no nerve damage from previous treatments.

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I have serious heart issues, including a recent heart attack or irregular heartbeat.

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I do not have an active or uncontrolled infection with HIV, Hepatitis B, or Hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Pain

Other study objectives

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

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