Observational

Study Title: Assessment for Long-Term Cardiovascular Impairment Associated With Trastuzumab Cardiotoxicity in HER2-Positive Breast Cancer Survivors

Study Type: Observational

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer
Center

Purpose: To study whether strain and exercise testing can be used to detect late signs of heart damage from chemotherapy in patients with a history of HER2-positive breast cancer

Primary Outcome Measures: Cardiac function [time frame: 2 years]

Principal Investigator: Anthony Yu, MD, Memorial Sloan Kettering Cancer Center; (212) 639-7932

ClinicalTrials.gov Identifier: NCT02615054

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Study Title: Cardiotoxicity of Radiation Therapy

Study Type: Observational

Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania

Purpose: To determine the utility of sensitive imaging and biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation doses to the heart

Primary Outcome Measures: Number of Cardiovascular injury [time frame: 8 months]

Principal Investigator: Bonnie Ky, MD, Abramson Cancer Center of the University of Pennsylvania; (855) 216-0098, penncancertrials@emergingmed.com

ClinicalTrials.gov Identifier: NCT02769299

Phase I

Study Title: Early Imaging Detection of Cardiovascular Injury After Cancer

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: Comprehensive Cancer Center of Wake Forest University, National Cancer ­Institute

Purpose: To study how well magnetic resonance imaging (MRI) works in detecting heart damage in patients with cancer receiving ­chemotherapy

Primary Outcome Measures: To correlate results of an automated MRI hardware/software platform for measuring left-ventricular function with manual results [time frame: up to 24 months]

Principal Investigator: William G. Hundley, MD, Comprehensive Cancer Center of Wake Forest University; (336) 716-6125, ghundley@wfubmc.edu

ClinicalTrials.gov Identifier: NCT01719562

Phase II

Study Title: A Phase II Pilot Study Using Metformin to Reduce Cardiac Toxicity in Breast Cancer Patients

Study Type: Interventional/parallel assignment

Study Sponsor and Collaborators: Avera McKennan Hospital & University Health Center

Purpose: To determine whether coadministration of metformin and doxorubicin in breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of patients who develop a significant change in left-­ventricular ejection fraction

Primary Outcome Measures: Left-ventricular ejection fraction [time frame: 1 year]

Principal Investigator: Kirstin ­Williams, CNP, Avera McKennan Hospital & University Health Center; (605) 322-6900, kirstinwilliams@avera.org

ClinicalTrials.gov Identifier: NCT02472353

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Study Title: Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin

Study Type: Interventional/parallel assignment

Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center

Purpose: To determine whether taking simvastatin while receiving doxorubicin for the treatment of breast cancer will minimize damage to the heart

Primary Outcome Measures: Change in echocardiographic global longitudinal strain [time frame: 10–15 weeks]

Principal Investigator: Karen Smith, MD, MPH, SKCCC at Johns Hopkins; (202) 660-6500, ksmith60@jhmi@edu

ClinicalTrials.gov Identifier: NCT02096588

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Study Title: Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial

Study Type: Interventional/parallel assignment

Study Sponsor and Collaborators: Cedars-Sinai Medical Center, California Breast Cancer Research Program

Purpose: To examine the effects of atorvastatin on changes to the heart among women undergoing breast cancer treatment

Primary Outcome Measures: Change in global circumferential strain measured by cardiac MRI [time frame: baseline to 12 months post-intervention initiation]

Principal Investigator: Marc Goodman, PhD, Cedars-Sinai Medical Center; contact Jaime Richardson (310) 423-2133, clinical.trial.info@cshs.org or Jenny Lester (310) 423-6241, jenny.lester@cshs.org

ClinicalTrials.gov Identifier: NCT02674204

Phase III

Study Title: Pragmatic Randomized Trial of Proton vs Photon Therapy for Patients With Nonmetastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

Study Type: Interventional/parallel assignment

Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania, Patient-Centered Outcomes Research Institute

Purpose: A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes

Primary Outcome Measures: Effectiveness of proton therapy vs photon therapy [time frame: 10 years]: Compare the effectiveness of proton vs photon therapy in reducing major cardiovascular events, defined as atherosclerotic coronary heart disease or other heart disease death; myocardial infarction; coronary revascularization; or hospitalization for a major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina)

Principal Investigator: Justin Bekelman, MD, Abramson Cancer Center of the University of Pennsylvania; (215) 662-7266, bekelman@uphs.upenn.edu

ClinicalTrials.gov Identifier: NCT02603341 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.

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