Trial Outcomes & Findings for A Study of Subcutaneously Administered Herceptin (Trastuzumab) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (NCT NCT01928615)
NCT ID: NCT01928615
Last Updated: 2014-09-29
Results Overview
Participants rated their quality of life on a visual analog scale (VAS) at the end of each cycle for Cycles 7-14. The left-end of the VAS represented the lowest-rated quality of life and the right-end of the VAS represented the highest-rated quality of life. Both the mean ratings for injections into the thigh and the upper arm and the minimum ratings for during injections into the thigh and the upper arm are reported. Quality of life scores ranged from 1 to 100 with a higher score indicating a better rated quality of life.
TERMINATED
PHASE2
2 participants
Cycles 7-14 (Weeks 19-42, 24 weeks total)
2014-09-29
Participant Flow
Neither of the 2 enrolled participants were randomized to 1 of the 2 crossover treatment arms. Randomization would not have occurred until after Cycle 6. Both participants only received 1 cycle of treatment.
Participant milestones
| Measure |
Trastuzumab
In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).
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Overall Study
STARTED
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2
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Trastuzumab
In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).
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Overall Study
Study Terminated by Sponsor
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2
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Baseline Characteristics
A Study of Subcutaneously Administered Herceptin (Trastuzumab) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab
n=2 Participants
In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).
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Age, Continuous
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38.0 years
STANDARD_DEVIATION 14.1 • n=99 Participants
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Sex: Female, Male
Female
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2 Participants
n=99 Participants
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Sex: Female, Male
Male
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0 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Cycles 7-14 (Weeks 19-42, 24 weeks total)Population: Modified intent-to-treat population: All participants who received at least 1 dose of study medication and who have at least 1 quality of life score in each treatment period (Cycles 7-10 and Cycle 11-14). Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed.
Participants rated their quality of life on a visual analog scale (VAS) at the end of each cycle for Cycles 7-14. The left-end of the VAS represented the lowest-rated quality of life and the right-end of the VAS represented the highest-rated quality of life. Both the mean ratings for injections into the thigh and the upper arm and the minimum ratings for during injections into the thigh and the upper arm are reported. Quality of life scores ranged from 1 to 100 with a higher score indicating a better rated quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 54 weeks)Population: Intent-to-treat population: All participants who received at least 1 dose of study medication. Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed.
Overall survival was defined as the time in months from Baseline to death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 54 weeks)Population: Intent-to-treat population: All participants who received at least 1 dose of study medication. Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed.
Disease-free survival was defined as the time in months from Baseline to disease recurrence or death, whichever occurred first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of Cycles 10 and 14 (Weeks 30 and 42)Population: Intent-to-treat population: All participants who received at least 1 dose of study medication. Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed.
The health care provider for each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of Cycles 10 and 14 (Weeks 30 and 42)Population: Intent-to-treat population: All participants who received at least 1 dose of study medication. Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed.
Each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of Cycle 14 (Week 42)Population: Intent-to-treat population: All participants who received at least 1 dose of study medication. Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed.
Participants were asked which of the 2 injection sites was their preferred site at the end of Cycle 14.
Outcome measures
Outcome data not reported
Adverse Events
Trastuzumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trastuzumab
n=2 participants at risk
In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant's choice) for 12 weeks (Cycles 15-18).
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Respiratory, thoracic and mediastinal disorders
Common cold
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50.0%
1/2
Intent-to-treat population: All participants who received at least 1 dose of study medication.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER