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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2-Positive Breast Cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left Ventricular Ejection Fraction | Diagnostic Test | LVEF assessment at baseline, 6 months, and 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Yu, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only) | Hartford | Connecticut | 06102 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36895062 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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• 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | HER2-Positive Breast Cancer | Left Ventricular Ejection Fraction: LVEF assessment at baseline, 6 months, and 12 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2022 |
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HER2-Positive Breast Cancer | Left Ventricular Ejection Fraction: LVEF assessment at baseline, 6 months, and 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Cardiac Adverse Events, Defined by a Compositive of Clinical Heart Failure (NYHA Class III or IV) or Cardiac Death. | Posted | Number | Cardiac AEs | 12 months from baseline |
|
|
|
1 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HER2-Positive Breast Cancer | Left Ventricular Ejection Fraction: LVEF assessment at baseline, 6 months, and 12 months | 1 | 190 | 1 | 190 | 8 | 190 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death NOS | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ventricular- systolic dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Disorders- Other specify | Cardiac disorders | Systematic Assessment |
| ||
| Edema: Limb | General disorders | Systematic Assessment |
| ||
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Ventricular arrhythmia-Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Yu, MD | Memorial Sloan Kettering Cancer Center | 212-639-5154 | yua3@mskcc.org |
| Aug 1, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
|