Trial Outcomes & Findings for Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification (NCT NCT02177175)
NCT ID: NCT02177175
Last Updated: 2022-07-12
Results Overview
Value at 3 months minus value at baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
3 months
Results posted on
2022-07-12
Participant Flow
11 participants were randomized to treatment. 71 participants were not randomized to treatment.
Participant milestones
| Measure |
Carvedilol
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
Carvedilol
|
Placebo
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Carvedilol
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
Carvedilol
|
Placebo
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
placebo
|
|---|---|---|
|
Overall Study
stopped trastuzumab so was taken off study
|
1
|
0
|
Baseline Characteristics
Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification
Baseline characteristics by cohort
| Measure |
Carvedilol
n=5 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
Carvedilol
|
Placebo
n=6 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
placebo
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 years
n=5 Participants
|
55.2 years
n=7 Participants
|
50.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsValue at 3 months minus value at baseline
Outcome measures
| Measure |
Carvedilol
n=5 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
Carvedilol
|
Placebo
n=6 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
placebo
|
|---|---|---|
|
Maximum Change in LVEF at 3 Months
|
1 change in percent ejection fraction
Interval -3.0 to 6.0
|
-5 change in percent ejection fraction
Interval -12.0 to 0.0
|
PRIMARY outcome
Timeframe: 6 monthsValue at 6 months minus value at baseline
Outcome measures
| Measure |
Carvedilol
n=5 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
Carvedilol
|
Placebo
n=6 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
placebo
|
|---|---|---|
|
Maximum Change in LVEF at 6 Months
|
-2 change in percent ejection fraction
Interval -7.0 to 1.0
|
-5 change in percent ejection fraction
Interval -7.0 to 4.0
|
PRIMARY outcome
Timeframe: 9 monthsValue at 9 months minus value at baseline
Outcome measures
| Measure |
Carvedilol
n=5 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
Carvedilol
|
Placebo
n=6 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
placebo
|
|---|---|---|
|
Maximum Change in LVEF at 9 Months
|
-3.5 change in percent ejection fraction
Interval -4.0 to -3.0
|
-5.5 change in percent ejection fraction
Interval -13.0 to 4.0
|
PRIMARY outcome
Timeframe: 12 monthsValue at 12 months minus value at baseline
Outcome measures
| Measure |
Carvedilol
n=5 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
Carvedilol
|
Placebo
n=6 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
placebo
|
|---|---|---|
|
Maximum Change in LVEF at 12 Months
|
-2.5 change in percent ejection fraction
Interval -4.0 to 1.0
|
-2 change in percent ejection fraction
Interval -13.0 to 4.0
|
SECONDARY outcome
Timeframe: 12 monthsThe study is designed to detect an intergroup difference of absolute difference of 10 percentage points (simple difference) in the change in LVEF between the experimental and control group. Ten percent is the change in LVEF that is associated with differing degrees of left ventricular dysfunction, and long-term studies among non-cancer patients have shown that outcomes differ among groups of patients who have LVEF differing by 10%.
Outcome measures
| Measure |
Carvedilol
n=5 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
Carvedilol
|
Placebo
n=6 Participants
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
placebo
|
|---|---|---|
|
Incidence of Abnormal LVEF at 12 Months
Abnormal LVEF
|
2 Participants
|
1 Participants
|
|
Incidence of Abnormal LVEF at 12 Months
Normal LVEF
|
3 Participants
|
5 Participants
|
Adverse Events
Carvedilol
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carvedilol
n=5 participants at risk
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
Carvedilol
|
Placebo
n=6 participants at risk
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
placebo
|
|---|---|---|
|
Infections and infestations
Skin infection
|
20.0%
1/5 • 12 months
|
0.00%
0/6 • 12 months
|
Other adverse events
| Measure |
Carvedilol
n=5 participants at risk
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
Carvedilol
|
Placebo
n=6 participants at risk
Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
placebo
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
60.0%
3/5 • 12 months
|
16.7%
1/6 • 12 months
|
|
Investigations
Alkaline phosphatase increased
|
80.0%
4/5 • 12 months
|
0.00%
0/6 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
5/5 • 12 months
|
100.0%
6/6 • 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
2/5 • 12 months
|
33.3%
2/6 • 12 months
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • 12 months
|
0.00%
0/6 • 12 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
20.0%
1/5 • 12 months
|
0.00%
0/6 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
60.0%
3/5 • 12 months
|
66.7%
4/6 • 12 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
2/5 • 12 months
|
33.3%
2/6 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.0%
1/5 • 12 months
|
0.00%
0/6 • 12 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/5 • 12 months
|
16.7%
1/6 • 12 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • 12 months
|
33.3%
2/6 • 12 months
|
|
Investigations
Lymphocyte count decreased
|
40.0%
2/5 • 12 months
|
33.3%
2/6 • 12 months
|
|
Investigations
Platelet count decreased
|
40.0%
2/5 • 12 months
|
33.3%
2/6 • 12 months
|
|
Investigations
White blood cell decreased
|
40.0%
2/5 • 12 months
|
50.0%
3/6 • 12 months
|
Additional Information
Dr. Anthony Yu, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7932
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place