Breast Cancer Clinical Trial
Official title:
A Safety and Feasibility Study of Limited Cardiac Monitoring During Non-anthracycline Trastuzumab-based Therapy in Patients With HER2-positive Breast Cancer
| Verified date | April 2024 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 194 |
| Est. completion date | March 2025 |
| Est. primary completion date | September 18, 2023 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center @ BaskingRidge (Consent and follow-up only) | Basking Ridge | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center @ Commack (Consent and Follow up) | Commack | New York |
| United States | Memorial Sloan Kettering Westchester (Consent and Follow-up) | Harrison | New York |
| United States | Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only) | Hartford | Connecticut |
| United States | Memorial Sloan Kettering Monmouth (Consent and Follow up) | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Bergen (Consent and follow-up only) | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Memorial Sloan Kettering Nassau (Consent and Follow-up) | Rockville Centre | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Participants have HER2-positive breast cancer treated with non-anthracycline trastuzumab-based therapy. | 12 months from baseline |
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