A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients
A Safety and Feasibility Study of Limited Cardiac Monitoring During Non-anthracycline Trastuzumab-based Therapy in Patients With HER2-positive Breast Cancer
1 other identifier
observational
190
1 country
8
Brief Summary
The purpose of this study is to test whether patients with breast cancer who are being treated with non-anthracycline trastuzumab therapy can safely be monitored for heart related side effects less often than usual.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2019
CompletedFirst Submitted
Initial submission to the registry
June 7, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2023
CompletedResults Posted
Study results publicly available
October 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
ExpectedMay 15, 2026
May 1, 2026
4.5 years
June 7, 2019
August 1, 2024
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of Cardiac Adverse Events, Defined by a Compositive of Clinical Heart Failure (NYHA Class III or IV) or Cardiac Death.
12 months from baseline
Study Arms (1)
HER2-Positive Breast Cancer
Interventions
LVEF assessment at baseline, 6 months, and 12 months
Eligibility Criteria
A member of the patient's treatment team, the protocol investigator, or research team at MSK will identify potential research participants. The preliminary screen of eligibility will be confirmation of the diagnosis of HER2-positive breast cancer. A member of the treatment team will discuss the study and the possibility of enrollment in the study with potential subjects that meet this eligibility criterion. The study will be conducted at the Evelyn H. Lauder Breast Center of MSK as well as at the regional MSK network sites. Recruitment at both main and regional network sites will ensure the enrollment of diverse populations of different ages, races, and ethnic groups onto the study. Patients will then be consented to the study. In most cases, the initial contact with the prospective subject will be conducted either by the treatment team, investigator or the research staff working in consultation with the treatment team.
You may qualify if:
- Age \>/= 18 years
- Newly diagnosed histologically confirmed primary invasive breast carcinoma (Stage I-IV)
- Pathologically confirmed HER2-positive breast cancer
- Planned to receive trastuzumab-based therapy for a minimum of 12 months, or started trastuzumab-based therapy within the last weeks with a planned duration of at least 12 months.
- Normal LV systolic function (EF greater than or equal to the institutional lower limit of normal)
- William and able to comply with the requirements of the protocol
You may not qualify if:
- Planned to receive an anthracycline-based regimen
- Prior history of treatment with anthracycline chemotherapy
- History of cardiovascular including cardiomyopathy, heart failure, or any other clinically significant cardiovascular disease (as determined by the investigator)
- Uncontrolled hypertension, defined as systolic blood pressure \>/= 160 mmHg and/or diastolic blood pressure \>/= 90 mmHg (as determined by the investigator)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only)
Hartford, Connecticut, 06102, United States
Memorial Sloan Kettering Cancer Center @ BaskingRidge (Consent and follow-up only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Commack (Consent and Follow up)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent and Follow-up)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent and Follow-up)
Rockville Centre, New York, 11553, United States
Related Publications (1)
Yu AF, Dang CT, Jorgensen J, Moskowitz CS, DeFusco P, Oligino E, Oeffinger KC, Liu JE, Steingart RM. Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy. Cardiooncology. 2023 Mar 9;9(1):13. doi: 10.1186/s40959-023-00163-4.
PMID: 36895062DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Anthony Yu, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony Yu, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2019
First Posted
June 12, 2019
Study Start
March 22, 2019
Primary Completion
September 18, 2023
Study Completion (Estimated)
March 1, 2027
Last Updated
May 15, 2026
Results First Posted
October 28, 2024
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.