Introduction
Materials and methods
Trial design
Eligibility
Intervention
Study endpoints
Statistical methods
Sample size calculation
Results
Patient characteristics
Variable | N (%) | |
---|---|---|
Race/ethnicity | ||
Non-Latino black | 17 (54.8) | |
Non-Latino white | 14 (45.2) | |
Hispanic/Latino | 2 (6.7) | |
BMI | ||
Normal (18.5 to < 25) | 5 (16.1) | |
Overweight (25 to < 30) | 10 (32.3) | |
Obese (> 30) | 16 (51.6) | |
Hypertension | 13 (41.9) | |
Diabetes | 5 (16.1) | |
Dyslipidemia | 12 (38.7) | |
Prior radiation therapy | 11 (35.5) | |
Prior anthracyclines | 17 (54.8) | |
Prior HER2-targeted therapy | ||
T | 12 (38.7) | |
T + P | 17 (54.8) | |
T-DM1 | 2 (6.4) | |
Breast cancer stage | ||
I-III | 18 (58.1) | |
IV | 13 (41.9) | |
HER2-targeted therapy received on study | ||
T | 15 (48.4) | |
T + P | 14 (45.2) | |
T-DM1 | 2 (6.4) | |
Beta blockers on study | Yes | 27 (90) |
ACEi/ARBs on study | Yes | 21 (70) |
LVEF results and cardiac events
Time point | Median LVEF (assessed by core lab), % [IQR] | P value | ||
---|---|---|---|---|
Overall study population (N = 30) | No events (N = 27) | CE or asymptomatic decline in LVEF (N = 3) | ||
Baseline | 45.0 [43, 47] | 46.0 [43, 47] | 43.0 [40, 44] | 0.10 |
6 weeks | 45.0 [43, 47] | 45.0 [43, 48] | 41.0 [40, 43] | 0.04 |
12 weeks | 47.5 [44, 53] | 49.0 [44, 53] | 41.0 [35, 45] | 0.07 |
24 weeks | 45.0 [41, 48] | 46.0 [41, 49] | 31.5 [25, 38] | 0.04 |
End of treatment (EOT) | 48.0 [42, 50] | 48.0 [43, 50] | 31.0 [29, 37] | 0.01 |
6 months post-EOT | 47.0 [45, 50] | 47.0 [45, 50] | 43.5 [41, 46] | 0.16 |