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A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03983382
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: Left Ventricular Ejection Fraction

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Study Type : Observational
Estimated Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Safety and Feasibility Study of Limited Cardiac Monitoring During Non-anthracycline Trastuzumab-based Therapy in Patients With HER2-positive Breast Cancer
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Group/Cohort Intervention/treatment
HER2-Positive Breast Cancer Diagnostic Test: Left Ventricular Ejection Fraction
LVEF assessment at baseline, 6 months, and 12 months
Other Name: LVEF




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months from baseline ]
    Participants have HER2-positive breast cancer treated with non-anthracycline trastuzumab-based therapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983382


Contacts
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Contact: Anthony Yu, MD 212-639-7932 yua3@mskcc.org
Contact: Chau Dang, MD 914-367-7181 dangc@mskcc.org

Locations
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United States, New Jersey
Memorial Sloan Kettering Cancer Center @ BaskingRidge (Consent and follow-up only) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Anthony Yu, MD    212-639-7932      
Memoral Sloan Kettering Monmouth (Consent and Follow up) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Anthony Yu, MD    212-639-7932      
Memorial Sloan Kettering Bergen (Consent and follow-up only) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Anthony Yu, MD    212-639-7932      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack (Consent and Follow up) Recruiting
Commack, New York, United States, 11725
Contact: Anthony Yu, MD    212-639-7932      
Memoral Sloan Kettering Westchester (Consent and Follow-up) Recruiting
Harrison, New York, United States, 10604
Contact: Anthony Yu, MD    212-639-7932      
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Anthony Yu, MD    212-639-7932      
Memorial Sloan Kettering Nassau (Consent and Follow-up) Recruiting
Rockville Centre, New York, United States, 11553
Contact: Anthony Yu, MD    212-639-7932      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Anthony Yu, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03983382     History of Changes
Other Study ID Numbers: 19-045
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: • 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
non-anthracycline trastuzumab
trastuzumab
Memorial Sloan Kettering Cancer Center
19-045
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents