Clinical trial NCT02674204: STOP Heart Disease in Breast Cancer Survivors Trial
Official title: Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Heart Disease
Cardiotoxicity
Myocardial Dysfunction
Keywords: Statin therapy
trastuzumab
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: California Breast Cancer Research Program
First posted: 2016-02-04
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.

Detailed description: This is a placebo-controlled study. It will compare the effects of atorvastatin against the effects of a placebo (an inactive substance, such as, a sugar pill) on changes to the heart before and during breast cancer treatment. Participants will be in the study for approximately a year and a half, and the study will enroll up to 60 patients. During that time, there will be six visits that may coincide with standard of care visits. Participants will also receive telephone calls from study staff during the study intervention and a follow-up phase to check-in with them.

Eligibility criteria: Inclusion Criteria:

* Female patients with newly diagnosed stage 1-3 breast cancer
* Histologically confirmed HER2, ER, and PR status
* Recommended to undergo trastuzumab treatment, with or without anthracycline. Patients will be eligible for up to 3 weeks after starting treatment.
* Age minimum 18 years
* Able and willing to read, understand, and sign an informed consent form (ICF) and medical release form
* Willing and able to comply with trial protocol and follow-up
* ECOG performance status 0-1 (Karnofsky ≥ 70%)

Exclusion Criteria:

* Prior use of statin medication within the past year
* Not using statin medication but is eligible for statin therapy based on the 2013 ACC/AHA guidelines (LDL cholesterol \>190, or LDL \<190 and ASCVD risk \>7.5%; http://tools.acc.org/ASCVD-Risk-Estimator/) and is \> 50 years old; or is eligible for statin therapy based on the 2013 ACC/AHA guidelines and is 40-50 years old and wishes to be placed on statin therapy
* History of adverse effects, intolerance, or allergic reactions attributed to statin medication
* Current use of gemfibrozil, cyclosporine, clarithromycin, itraconazole, erythromycin, the hepatitis C protease inhibitor telaprevir, HIV protease inhibitors, colchicine, or red yeast rice
* Current use of any other investigational agent
* Pregnant or intention to get pregnant during the next 18 months. Pregnant women are excluded from this study because atorvastatin is a lipid-lowering agent with the potential for teratogenic or abortifacient effects, and MRI is contraindicated in pregnant women.
* History of diabetes, severe lung disease, renal disease (creatinine \> 1.8 mg/dL or CrCl ≤ 50 mL/min), or hepatic disease (AST and ALT \> 3 times upper normal limits)
* Abnormal baseline echocardiogram or cardiac MRI (detection of congenital heart disease; ischemic heart disease; moderate or severe valvular heart disease; cardiomyopathy; EF \< 55%)
* Previously known or diagnosed heart disease (e.g. congenital; valvular; coronary artery disease; history of myocardial infarction or acute coronary syndrome; cardiomyopathy, including infiltrative, hypertensive, hypertrophic, dilated, constrictive pericarditis, or other cardiomyopathy)
* Left ventricular dysfunction (EF \< 55%)
* Prior non-cardiac illness with an estimated life expectancy \< 4 years
* Known active infection with HIV
* Allergy or contraindication to MRI testing, including claustrophobia, metallic parts in body the prohibiting MRI, prior gadolinium contrast reaction, or uncontrolled moderate hypertension (sitting blood pressure \>160/95 mm Hg with measurements recorded on at least 2 occasions).
* Has metallic breast expanders in place at the time of screening
* Concurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the data

Primary outcomes:
measure: Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)
timeFrame: baseline to 12 months post initiation of statin intervention
Secondary outcomes:
measure: Change in Global Longitudinal Strain as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Peak Left Ventricular Twist as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Peak Left Ventricular Torsion as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Left Ventricular Untwisting Rate as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Left Ventricular Ejection Fraction as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Left Ventricular End Diastolic Volume as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Left Ventricular End Systolic Volume as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Cardiac Output as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Left Ventricular Mass as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Left Ventricular Concentricity as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Native T1 as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Post Contrast T1 as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Extracellular Volume as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
measure: Change in Native T2 as Measured by CMRI
timeFrame: Baseline to 12 months of follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinal Medical Center
name: Marc Goodman, PhD
role: PRINCIPAL_INVESTIGATOR
References: