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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ five years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five years
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 moreSide effects data
From 2013 Phase 3 trial • 59 Patients • NCT0100440614%
Chest pain
14%
Sinusitis
10%
Otitis externa
10%
Musculoskeletal pain
5%
Hypertension
5%
Coronary artery disease
5%
Catheter site haemorrhage
5%
Hypertensive crisis
5%
Leukocytosis
5%
Ischaemic cardiomyopathy
5%
Atrial fibrillation
5%
Cholecystitis acute
5%
Dizziness
5%
Angina unstable
5%
Abdominal discomfort
5%
Gallbladder disorder
5%
Tachycardia
5%
Headache
5%
Sinus bradycardia
5%
Medical device complication
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
429 Previous Clinical Trials
64,172 Total Patients Enrolled
Mridula George, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
54 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use effective birth control during my treatment.I am allergic to one or more of the drugs used in this study.I currently have an active infection.My kidney function is within the required range.I am scheduled for treatment targeting HER2 before/after surgery.I have been diagnosed with Stage I-III breast cancer.I do not have any health issues that would stop me from joining the study.I am currently taking medication that affects liver enzyme CYP 3A4.You are expected to live for less than 12 weeks.I am 18 years old or older.I have not fully recovered from a major surgery within the last 4 weeks.I have a history of lung conditions like interstitial lung disease or sarcoidosis.I have been cancer-free for the last 5 years.I am willing and able to follow the study's schedule and procedures.I am a woman who can have children and have a negative pregnancy test.My breast cancer is at stage IV.I am currently taking statin medication.Your blood pressure is not well controlled (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg).I do not have any active liver disease.I have mild or no nerve damage from previous treatments.You are pregnant or breastfeeding.I have serious heart issues, including a recent heart attack or irregular heartbeat.I do not have an active or uncontrolled infection with HIV, Hepatitis B, or Hepatitis C.I can take care of myself and perform daily activities.Your heart's pumping function is normal.I have never been treated with HER2 targeted therapy or anthracycline-based chemotherapy.My blood tests show normal white blood cells, platelets, and hemoglobin levels.My liver tests are within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Anti-HER2 targeted therapy + Lipitor 40mg daily
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity to join this research endeavor?
"As indicated by clinicaltrials.gov, enrollment in this medical study is now open; the trial was first made available on September 19th 2022 and subsequently updated on February 21st 2023."
Answered by AI
What deleterious effects could potentially arise from the combination of Anti-HER2 targeted therapy and Lipitor 40mg daily?
"Our Power team rated the safety of Anti-HER2 targeted therapy and Lipitor 40mg daily a 2, as this is only currently at Phase 2. This suggests that there have been some studies confirming its safety but none to demonstrate efficacy."
Answered by AI
Are there numerous sites in the US carrying out this research?
"Thirteen different medical centres are offering this trial, including Monmouth Community Medical in Long Branch, RWJBarnabas Health - Community Medical Center in Toms River and Trinitas Hospital and Comprehensive Cancer Centre in Elizabeth."
Answered by AI
What is the maximum capacity of participants in this clinical trial?
"Affirmative. Clinicaltrials.gov's records show that this study, which was first published on September 19th 2022, is actively recruiting participants. Sixty volunteers need to be sourced from 13 different medical sites."
Answered by AI
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