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Trial record 147 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Adverse Drug Events" OR "Adverse Drug Reactions" OR "Drug Related Side Effects"

STOP Heart Disease in Breast Cancer Survivors Trial (STOP)

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ClinicalTrials.gov Identifier: NCT02674204
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
California Breast Cancer Research Program
Information provided by (Responsible Party):
Marc Goodman, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Heart Disease Cardiotoxicity Myocardial Dysfunction Drug: Atorvastatin Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial
Actual Study Start Date : May 5, 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Experimental: Study Agent
One atorvastatin 20 mg oral capsule per day
Drug: Atorvastatin
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.
Other Names:
  • Lipitor
  • Atorvastatin calcium

Placebo Comparator: Control
One matching placebo daily
Drug: Placebo
A substance that has no therapeutic effect, and will be used as a control in testing the study agent.




Primary Outcome Measures :
  1. Change in global circumferential strain (GCS) measured by Cardiac MRI (CMRI) [ Time Frame: baseline to 12 months post initiation of statin intervention ]

Secondary Outcome Measures :
  1. Change in global longitudinal strain as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  2. Change in peak left ventricular twist as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  3. Change in peak left ventricular torsion as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  4. Change in left ventricular untwisting rate as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  5. Change in left ventricular ejection fraction as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  6. Change in left ventricular end diastolic volume as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  7. Change in left ventricular end systolic volume as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  8. Change in cardiac output as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  9. Change in left ventricular mass as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  10. Change in left ventricular concentricity as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  11. Change in native T1 as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  12. Change in post contrast T1 as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  13. Change in extracellular volume as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]
  14. Change in native T2 as measured by CMRI [ Time Frame: Baseline to 12 months of follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674204


Contacts
Contact: Emily Hautamaki, RN, MPH 310-423-2133 clinical.trial.info@cshs.org
Contact: Jenny Lester 310-423-6241 Jenny.Lester@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Emily Hautamaki    310-423-0347    Emily.Hautamaki@cshs.org   
Contact: Jenny Lester    310-423-6241    Jenny.Lester@cshs.org   
Principal Investigator: Marc Goodman, PhD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
California Breast Cancer Research Program
Investigators
Principal Investigator: Marc Goodman, PhD Cedars-Sinal Medical Center

Responsible Party: Marc Goodman, Professor and Director, Cancer Prevention & Control - Department, Cancer Institute, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02674204     History of Changes
Other Study ID Numbers: IIT2015-12-Goodman-STOP
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marc Goodman, Cedars-Sinai Medical Center:
Statin therapy
trastuzumab

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Breast Neoplasms
Heart Diseases
Cardiotoxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cardiovascular Diseases
Pathologic Processes
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors