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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03983382

Collaborator

(none)

194

Enrollment

Locations

47.3

Anticipated Duration (Months)

24.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Breast Cancer	Diagnostic Test: Left Ventricular Ejection Fraction

Study Design

Study Type:

Observational

Anticipated Enrollment :

194 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 :

Mar 22, 2019

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
HER2-Positive Breast Cancer	Diagnostic Test: Left Ventricular Ejection Fraction LVEF assessment at baseline, 6 months, and 12 months Other Names: LVEF

Arm

Intervention/Treatment

HER2-Positive Breast Cancer

Diagnostic Test: Left Ventricular Ejection Fraction

LVEF assessment at baseline, 6 months, and 12 months

Other Names:

LVEF

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only)	Hartford	Connecticut	United States	06102
2	Memorial Sloan Kettering Cancer Center @ BaskingRidge (Consent and follow-up only)	Basking Ridge	New Jersey	United States	07920
3	Memoral Sloan Kettering Monmouth (Consent and Follow up)	Middletown	New Jersey	United States	07748
4	Memorial Sloan Kettering Bergen (Consent and follow-up only)	Montvale	New Jersey	United States	07645
5	Memorial Sloan Kettering Cancer Center @ Commack (Consent and Follow up)	Commack	New York	United States	11725
6	Memoral Sloan Kettering Westchester (Consent and Follow-up)	Harrison	New York	United States	10604
7	Memorial Sloan - Kettering Cancer Center	New York	New York	United States	10021
8	Memorial Sloan Kettering Nassau (Consent and Follow-up)	Rockville Centre	New York	United States	11553