TerminatedNCT02674204STOPUpdated May 15, 2019Results posted

STOP Heart Disease in Breast Cancer Survivors Trial

A Phase 2 interventional study of Atorvastatin and Placebo in Breast Cancer, Heart Disease and Cardiotoxicity, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-15.

Sponsored by Cedars-Sinai Medical Center · Phase 2, Interventional, and Treatment

Why this study was terminated

Closed due to low accrual

Phase: Phase 2
Study type: Interventional
Enrollment: 2
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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.

Read the 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.

Conditions studied

Breast Cancer
Heart Disease
Cardiotoxicity
Myocardial Dysfunction

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Keywords

Statin therapy
trastuzumab

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 2 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 2 participants (actual)

Study arms

Experimental
Study Agent
One atorvastatin 20 mg oral capsule per day
Drug: Atorvastatin
Placebo comparator
Control
One matching placebo daily
Drug: Placebo

Interventions

DrugAtorvastatin
Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
Also known as: Lipitor, Atorvastatin calcium
DrugPlacebo
A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

What researchers measure

Primary outcomes

Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)
Time frame: baseline to 12 months post initiation of statin intervention

Secondary outcomes

Change in Global Longitudinal Strain as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Peak Left Ventricular Twist as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Peak Left Ventricular Torsion as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Untwisting Rate as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Ejection Fraction as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular End Diastolic Volume as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular End Systolic Volume as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Cardiac Output as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Mass as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Concentricity as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Native T1 as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Post Contrast T1 as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Extracellular Volume as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Native T2 as Measured by CMRI
Time frame: Baseline to 12 months of follow-up

Results

Posted Apr 30, 2019

Limitations and caveats

Accrual fell well below target. Two subjects were randomized to the study and one subject completed the study. Outcome measures were not analyzed due to insufficient accrual.

Participant flow

Participant flow — Overall Study
Milestone	Study Agent	Control
Started	1	1
Completed	0	1
Not completed	1	0
Withdrew: Adverse event	1	0