Prospective Evaluation Of Carvedilol In Prevention Of Cardiac Toxicity In Patients With Metastatic Her-2+ Breast Cancer, Phase III
Posted Date: Oct 21, 2021
- Investigator: Mahmoud Charif
- Specialties: Breast Cancer, Cancer, Cardiovascular Disease, Oncology
- Type of Study: Drug
This phase III trial will study how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy. Efficacy will be determined by the time to the first identification of cardiac dysfunction. There will be 3 arms in this study. Arm 1 will have patients not taking beta blocker, ARB, or ACE inhibitor at registration receive carvedilol PO BID. Courses repeat every 12 weeks for 108 weeks in the absence of disease progression or unacceptable toxicity. Arm 2 will have patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks. Arm 3 Patients will undergo observation for up to 108 weeks.
Patients Must Have Metastatic Breast Cancer And Be Initiating Within 7 Days Of Step 1 Registration Or Continuing Trastuzumab Based Her-2 Targeted Therapy Without Concurrent Anthracyclines In First Or Second Line Setting. Patients Must Be At Increased Risk For Cardiotoxicity. Patients Must Not Have Taken Within 21 Days Prior To Step 1 Registration, Be Currently Taking At The Time Of Step 1 Registration, Or Planning To Take Once Registered To Step 1 A Beta Blocker, Arb, Or Ace Inhibitor In Order To Be Randomized (Arms 1 And 2). Patients Must Not Be Currently Taking Or Planning To Take During Study Treatment The Following Medications: B2 Agonists, Bosutinib, Ceritinib, Floctafenine, Methacholine, Pazopanib, Rivastigmine, Vincristine, Silodosin. Patients Must Have A Zubrod Performance Status Of 0-2. Patients Must Have A Complete Physical Examination And Medical History Within 28 Days Prior To Registration. Patients Must Have Lvef >= 50% By 2-Dimensional (D) Echocardiogram Within 28 Days Prior To Registration. Serum Bilirubin < 3.0 X Institutional Upper Limit Of Normal (Iuln). Serum Glutamic Oxaloacetic Transaminase (Sgot)/Aspartate Aminotransferase (Ast) And Serum Glutamic Pyruvic Transaminase (Sgpt)/Alanine Aminotransferase (Alt) < 5.0 X Iuln. Patients Must Have Electrocardiogram With Corrected Qt (Qtc) With Correction Within 28 Days Prior To Registration. Patients Must Have A Systolic Blood Pressure >= 80 Mm Hg Within 14 Days Prior To Registration. Patients Must Not Be Dialysis Dependent. Patients Must Be Able To Swallow Tablets. Patients Must Not Have Uncontrolled Asthma. Patients Must Not Co-Enroll On Other Treatment Trials. No Other Prior Malignancy Is Allowed Except For The Following: Adequately Treated Basal Cell Or Squamous Cell Skin Cancer, In Situ Cervical Cancer, Prostate Cancer On Active Surveillance, Adequately Treated Stage I Or Ii Cancer From Which The Patient Is Currently In Complete Remission, Or Any Other Cancer From Which The Patient Has Been Disease Free For Five Years. Patients Must Not Be Registered To Step 2 Until Receiving Confirmation From The Echo Core Lab That The Patients Lvef By Echocardiogram Was >= 50% By Central Review; Patients Must Be Registered Within 5 Calendar Days Of Receiving The E-Mail Notification.
Phase 3, Breast Cancer, Cardiac
For More Information:
Uc Cancer Center