Breast Cancer
Conditions
Keywords
non-anthracycline trastuzumab, trastuzumab, Memorial Sloan Kettering Cancer Center, 19-045
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.
Interventions
DIAGNOSTIC_TESTLeft Ventricular Ejection Fraction
LVEF assessment at baseline, 6 months, and 12 months
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnthony Yu, MD
Memorial Sloan Kettering Cancer Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HER2-Positive Breast Cancer Left Ventricular Ejection Fraction: LVEF assessment at baseline, 6 months, and 12 months | 190 |
| Total | 190 |
Baseline characteristics
| Characteristic | HER2-Positive Breast Cancer |
|---|---|
| Age, Continuous | 52 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 158 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 139 Participants |
| Region of Enrollment United States | 190 Participants |
| Sex: Female, Male Female | 190 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 190 |
| other Total, other adverse events | 8 / 190 |
| serious Total, serious adverse events | 1 / 190 |
Outcome results
Primary
Frequency of Cardiac Adverse Events, Defined by a Compositive of Clinical Heart Failure (NYHA Class III or IV) or Cardiac Death.
Time frame: 12 months from baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HER2-Positive Breast Cancer | Frequency of Cardiac Adverse Events, Defined by a Compositive of Clinical Heart Failure (NYHA Class III or IV) or Cardiac Death. | 0 Cardiac AEs |