Breast Cancer Clinical Trial

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

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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.

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Eligibility 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)

Study is for people with:

Breast Cancer

Estimated Enrollment:

194

Study ID:

NCT03983382

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 8 Locations for this study

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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
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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

194

Study ID:

NCT03983382

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
Clinical Trials for Breast Cancer
Have You Been Diagnosed With Late-Stage Breast Cancer? Know That You Have Treatment Options.
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