Back to search results

Observational Study of Cardiac Risk in HER2-Positive Metastatic Breast Cancer

This study is for patients with HER2-positive metastatic breast cancer (cancer that has spread) who are receiving trastuzumab-based therapy. It aims to understand how often heart problems (cardiac toxicity) occur in these patients. The study has two parts: an observational group, which is currently open, and a randomized group, which is closed. The observational group includes patients already taking heart medications like carvedilol, ACE inhibitors, or ARBs along with their trastuzumab. The main goal is to see how many patients develop heart issues over two years and to identify factors that might predict this risk. You must be at least 18 years old and starting or continuing trastuzumab-based therapy for metastatic disease to be eligible. The study is currently recruiting for its observational cohort.

Study design
This is an interventional study with a planned enrollment of 491 participants. It includes an observational cohort and a randomized cohort, though the randomized cohort is currently closed to new participants.
What's involved
Participants will undergo observation and may have laboratory biomarker analysis. The primary endpoint is measured up to 108 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, time to the first identification of cardiac dysfunction, is measured up to 108 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03418961

S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity

Recruiting
PHASE3Ages 18+InterventionalSupportive care
SWOG Cancer Research Network
~491 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:CarvedilolLaboratory Biomarker AnalysisPatient Observation

At a glance

Recruiting sites
145 of 590 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to the first identification of cardiac dysfunction
Measured over Up to 108 weeks

Conditions

Cardiotoxicity
HER2/Neu Positive
Metastatic Malignant Neoplasm in the Brain
Recurrent Breast Carcinoma
Stage IV Breast Cancer AJCC v6 and v7

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

590 sites across 45 states
Michigan74
Washington51
Ohio49
California45
Illinois40
Missouri35
Minnesota30
Colorado21

Study leadership

  • Justin Floyd · PRINCIPAL_INVESTIGATOR · SWOG Cancer Research Network

Who to contact

Site Public Contact
[email protected]
800-826-4673
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

STEP 1 REGISTRATION
Trastuzumab or a trastuzumab biosimilar
Trastuzumab + chemotherapy or hormonal therapy
Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab, lapatinib, and tucatinib)
Ado-trastuzumab (Kadcyla®)
Fam-trastuzumab deruxtecan (Enhertu) 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:
LVEF 50-54% by local ECHO read\*
Age ≥ 65
BMI ≥ 30 kg/m2
Current or prior anti-hypertensive therapy
Diagnosis of coronary artery disease (CAD)
Diagnosis of diabetes mellitus
Diagnosis of atrial fibrillation/flutter Note: ECHO can be performed at any time prior to registration with the most recent being sent.
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 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% echocardiogram (2D or 3D) 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.
Patients must have adequate hepatic function as evidenced by all of the following 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 not be dialysis dependent
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
For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and CIRB regulations.
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 confirming via RAVE EDC that the patient's LVEF by echocardiogram was \>= 50% by central review. Patients must be registered within 21 calendar days of submission of the ECHO study/
Site must verify that there is no known change in the step 1 eligibility since initial registration

What this trial measures

  • Time to the first identification of cardiac dysfunctionUp to 108 weeks

    Real-time, blinded, central echocardiography (ECHO) read as a decrease in the left ventricular ejection fraction (LVEF) of \>= 10 percentage points from baseline to a value of \< 50% OR decrease of LVEF by \>= 5 percentage points from baseline to LVEF \< 50% in those baselines having a baseline LVEF of 50-54%. The distributions of time to cardiac dysfunction will be described using cumulative incidence estimates, with the statistical significance of treatment arm differences assessed by Cox and Fine-Gray regression models with adjustment for stratification factors. Gray's test will also be applied