S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer
Launched by SWOG CANCER RESEARCH NETWORK · Jan 31, 2018
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called S1501, is investigating whether a medication called carvedilol can help prevent heart problems in patients with metastatic HER-2-positive breast cancer. This type of cancer has spread to other parts of the body, and patients are often treated with chemotherapy, which can sometimes harm the heart. Carvedilol is a beta-blocker commonly used to treat heart failure and high blood pressure, and researchers want to see if it can protect the heart from chemotherapy side effects.
To be eligible for this trial, patients need to have metastatic breast cancer and be starting or continuing specific HER-2-targeted treatments. They should also be at higher risk for heart issues due to factors like age, weight, or previous heart treatments. Participants will undergo several health checks, including heart tests, and if eligible, they will be randomly assigned to receive either carvedilol or no treatment. Throughout the trial, patients can expect regular monitoring of their heart health and overall well-being. It’s important for participants to understand that they will need to provide informed consent and may have to follow specific guidelines during the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • STEP 1 REGISTRATION
- * 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 may have brain metastasis; there is no limit for number of doses of HER-2 targeted therapy prior to registration; examples of eligible HER-2 targeted therapy:
- • Trastuzumab
- • Trastuzumab + chemotherapy or hormonal therapy
- • Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab)
- • Ado-trastuzumab (Kadcyla)
- • NOTE: Patients on lapatinib without trastuzumab are not eligible; planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted
- * Patients must be at increased risk for cardiotoxicity defined by at least one of the following:
- • Previous anthracycline exposure, OR
- * 1 or more of the following risk factors for heart disease:
- • Left ventricular ejection fraction (LVEF) 50-54% by local echocardiography (ECHO) read
- • Age \>= 65
- • Body mass index (BMI) \>= 30 kg/m\^2
- • Current or prior anti-hypertensive therapy
- • Diagnosis of coronary artery disease (CAD)
- • Diabetes mellitus
- • Atrial fibrillation/flutter
- • 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 currently taking a beta blocker, ARB, or ACE inhibitor at the time of step 1 registration are eligible to register for the non-randomized observational cohort (Arm 3)
- * 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; the echocardiogram must be obtained from a S1501 validated ECHO laboratory (lab) and submitted for central review by the S1501 ECHO core lab; ECHO should not be submitted for central read until patient has been otherwise deemed eligible
- • 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 pregnant or nursing due to potential fetal or nursing infant harm; women/men of reproductive potential must have agreed to use an effective contraceptive method, a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
- • Patients must be willing to submit blood specimens
- • Sites must seek additional patient consent for the future use of specimens
- • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- • STEP 2 REGISTRATION (Randomization)
- • Patients must not be registered to step 2 until receiving confirmation from the ECHO Core Lab that the patient?s LVEF by echocardiogram was \>= 50% by central review; patients must be registered within 5 calendar days of receiving the e-mail notification
- • Site must verify that there is no known change in the step 1 eligibility since initial registration
About Swog Cancer Research Network
The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
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Flint, Michigan, United States
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Macomb, Michigan, United States
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Warren, Michigan, United States
Warren, Michigan, United States
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Goyang Si, Gyeonggi Do, Korea, Republic Of
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Westlake, Ohio, United States
Lansing, Michigan, United States
Coffeyville, Kansas, United States
North Kansas City, Missouri, United States
Tawas City, Michigan, United States
Warrensville Heights, Ohio, United States
Seattle, Washington, United States
Fort Worth, Texas, United States
Beavercreek, Ohio, United States
Clinton, South Carolina, United States
Martinsburg, West Virginia, United States
Bayamon, , Puerto Rico
Manati, , Puerto Rico
Hibbing, Minnesota, United States
Virginia, Minnesota, United States
Hazleton, Pennsylvania, United States
Collierville, Tennessee, United States
Ashland, Wisconsin, United States
Honolulu, Hawaii, United States
Ballwin, Missouri, United States
Washington, Missouri, United States
Lafayette, Colorado, United States
Honolulu, Hawaii, United States
Mooresville, Indiana, United States
Redmond, Oregon, United States
Mission Hills, California, United States
Chadds Ford, Pennsylvania, United States
Aguadilla, , Puerto Rico
Arecibo, , Puerto Rico
Bayamon, , Puerto Rico
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Santa Isabel, , Puerto Rico
Upland, California, United States
Frankford, Delaware, United States
Lafayette, Indiana, United States
Newton, New Jersey, United States
Covington, Louisiana, United States
Savannah, Georgia, United States
Richardson, Texas, United States
Bloomfield, Michigan, United States
Baton Rouge, Louisiana, United States
Torrance, California, United States
Baton Rouge, Louisiana, United States
Newport Beach, California, United States
Seattle, Washington, United States
Des Moines, Iowa, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Danville, Illinois, United States
Patients applied
Trial Officials
Justin Floyd
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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