Major Program
Supportive Care and Symptom Management
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
SWOG Cancer Research Network
Status
Recruiting
NCT ID
NCT03418961
This trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment. Both cohorts are being observed for cardiac toxicity. The largest cohort (currently open to accrual) is observational, and contains patients who are taking a beta blocker, ACE inhibitor, or ARB as well as their trastuzumab-based treatment. The goal is to understand how common cardiac problems are in this group of patients at high risk. The smaller cohort (currently closed to accrual) is randomized. Patients in this second cohort are randomized to either carvedilol or no treatment, with the goal of seeing whether carvedilol (used to treat heart failure and high blood pressure) may prevent the heart from side effects of chemotherapy.
Intervention
Carvedilol, Laboratory Biomarker Analysis, Patient Observation
Condition
Cardiotoxicity, HER2/Neu Positive, Metastatic Malignant Neoplasm in the Brain, Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
Investigators
Justin Floyd, Ashkan Bahrani, Shelly S. Lo, Bryan A. Faller, Erin F. Cobain, Sunitha Vemulapalli, Jay W. Carlson, Cynthia M. Vakhariya, Kathleen J. Yost, Sailendra Vasireddy, Sung Ho B. Lee, Richard L. Deming, Barbara S. Craft, Halle C. Moore, David M. King, Hadeel Assad, Joanne E. Mortimer, Gregory A. Masters, Martine Extermann, Abdul Hai Mansoor, Anne P. O'Dea, Charles H. Nash, John M. Schallenkamp, Gina G. Chung, Thomas E. Lad, Jacklyn M. Nemunaitis, Naveed A. Rana, Bonni L. Guerin, Rachel L. Yung, Lisa Bailey, Josh D. Simmons, Yadyra Rivera, Kathryn M. Leininger, Ki Y. Chung, Charles W. Drescher, Priya Jayachandran, Alison E. Spellman, Marshall P. Stagg, Tareq Al Baghdadi, Haythem Y. Ali, Dan Costin, Bahar Moftakhar, Mahmoud Charif, Alexandra d. Zimmer, Monali K. Vasekar, Joyson Poulose, Vlad G. Zaha, Robert M. Kyler, Victor T. Lin, Site Public Contact, Keun Seok Lee, Amelia B. Zelnak, Andrew Piper-Vallillo, Iftekhar A. Khan, Shahzad Siddique, Kevin M. Kalinsky, Danish Safi
CT Research Area
Symptom Science