Clinical Trial Results:
LISAH: AN OPEN-LABEL, RANDOMISED PHASE II STUDY ASSESSING QUALITY OF LIFE ASSOCIATED WITH SUBCUTANEOUS TRASTUZUMAB INJECTED INTO THE THIGH OR UPPER ARM IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER
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Summary
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EudraCT number |
2013-001023-39 |
Trial protocol |
AT |
Global end of trial date |
18 Oct 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
04 May 2016
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First version publication date |
06 Aug 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ML28786
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01928615 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche AG
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4070
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Public contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
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Scientific contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Oct 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Oct 2013
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess the Quality of Life in Human Epidermal Growth Factor 2 (HER2) - positive early breast cancer patients treated with trastuzumab solution injected subcutaneously into the thigh versus upper arm.
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Protection of trial subjects |
This study will be conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Sep 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 2
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Worldwide total number of subjects |
2
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EEA total number of subjects |
2
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
2
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||
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Pre-assignment
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Screening details |
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. | ||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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Trastuzumab | ||||||||||
Arm description |
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). | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Trastuzumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion, Solution for injection
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Routes of administration |
Intravenous use, Subcutaneous use
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Dosage and administration details |
8 mg/kg loading dose in Cycle1 followed by 6 mg/kg maintenance dose from Cycle 2 to Cycle 6 (3-week cycles) administered intravenously. A 600 mg subcutaneous injection from Cycle 7 to Cycle 18.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
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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End points reporting groups
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Reporting group title |
Trastuzumab
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Reporting group description |
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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End point title |
Quality of Life Score [1] | ||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
Cycles 7-14 (Weeks 19-42, 24 weeks total)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Since the study was terminated by the sponsor, endpoints were not analyzed and no statistical analyses were performed. |
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| Notes [2] - Due to premature termination of the study, the Outcome Measure was not analyzed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Overall Survival | ||||||||
End point description |
Overall survival was defined as the time in months from Baseline to death from any cause.
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End point type |
Secondary
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End point timeframe |
Baseline to the end of the study (up to 54 weeks)
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| Notes [3] - Due to premature termination of the study, the Outcome Measure was not analyzed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Disease-free Survival | ||||||||
End point description |
Disease-free survival was defined as the time in months from Baseline to disease recurrence or death, whichever occurred first.
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End point type |
Secondary
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End point timeframe |
Baseline to the end of the study (up to 54 weeks)
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| Notes [4] - Due to premature termination of the study, the Outcome Measure was not analyzed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Health Care Provider’s Satisfaction With the Injection Site | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
End of Cycles 10 and 14 (Weeks 30 and 42)
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| Notes [5] - Due to premature termination of the study, the Outcome Measure was not analyzed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Participant’s Satisfaction With the Injection Site | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
End of Cycles 10 and 14 (Weeks 30 and 42)
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| Notes [6] - Due to premature termination of the study, the Outcome Measure was not analyzed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Preferring Each Injection Site | ||||||||
End point description |
Participants were asked which of the 2 injection sites was their preferred site at the end of Cycle 14.
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End point type |
Secondary
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End point timeframe |
End of Cycle 14 (Week 42)
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| Notes [7] - Due to premature termination of the study, the Outcome Measure was not analyzed. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From the date of first dose of study drug administration until study termination.
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Adverse event reporting additional description |
Intent-to-treat population: All participants who received at least 1 dose of study medication.
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Assessment type |
Non-systematic | ||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
16
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Reporting groups
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Reporting group title |
Trastuzumab
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Reporting group description |
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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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
