Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in HER2-positive Early Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01401166
First received: July 22, 2011
Last updated: June 3, 2015
Last verified: June 2015
Results First Received: February 9, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Trastuzumab subcutaneously
Drug: Trastuzumab intravenously
Biological: Recombinant humanized hyaluronidase

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
248 participants were randomized into the study in Cohort 1 (of which 244 were treated) and 240 participants were randomized into the study in Cohort 2 (of which 239 were treated).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
4 participants in the trastuzumab subcutaneously then trastuzumab intravenously group and 1 participant in the trastuzumab intravenously then trastuzumab subcutaneously group did not receive any treatment and were not included in Participant Flow.

Reporting Groups
  Description
Trastuzumab Subcutaneously Then Trastuzumab Intravenously Participants received trastuzumab on Day 1 of each 3-week cycle for 8 cycles of the crossover period. During cycles 1-4, they received trastuzumab 600 mg subcutaneously (SC) and during cycles 5-8, they received trastuzumab 6 mg/kg intravenously (IV).
Trastuzumab Intravenously Then Trastuzumab Subcutaneously Participants received trastuzumab on Day 1 of each 3-week cycle for 8 cycles of the crossover period. During cycles 1-4, they received trastuzumab 6 mg/kg intravenously (IV) and during cycles 5-8, they received trastuzumab 600 mg subcutaneously (SC). In case Cycle 1 of the cross-over period was the first cycle of trastuzumab treatment, a loading dose of trastuzumab 8 mg/kg IV was administered.
Cohort 1 Participants received trastuzumab 6 mg/kg intravenously on Day 1 of each 3-week cycle for up to 10 remaining cycles. Participants in Cohort 1, who had at least 2 treatment cycles remaining of their 18-cycle treatment course, were offered the opportunity to self-administer trastuzumab 600 mg subcutaneously using the single-injection device on Day 1 of each 3-week cycle under the direction of a trained health care practitioner. Following the end of treatment, participants were followed for 3 years for safety.
Cohort 2 Participants received trastuzumab 600 mg/kg subcutaneously on Day 1 of each 3-week cycle for up to 10 remaining cycles. Following the end of treatment, participants were followed for 3 years for safety.

Participant Flow for 4 periods

Period 1:   Crossover Treatment 1
    Trastuzumab Subcutaneously Then Trastuzumab Intravenously     Trastuzumab Intravenously Then Trastuzumab Subcutaneously     Cohort 1     Cohort 2  
STARTED     243     240     0 [1]   0 [1]
COMPLETED     243     240     0     0  
NOT COMPLETED     0     0     0     0  
[1] There were no participants in this reporting group in this period.

Period 2:   Crossover Treatment 2
    Trastuzumab Subcutaneously Then Trastuzumab Intravenously     Trastuzumab Intravenously Then Trastuzumab Subcutaneously     Cohort 1     Cohort 2  
STARTED     241 [1]   237 [1]   0 [2]   0 [2]
COMPLETED     241     237     0     0  
NOT COMPLETED     0     0     0     0  
[1] Not all participants who completed crossover treatment 1 started crossover treatment 2.
[2] There were no participants in this reporting group in this period.

Period 3:   Continuation Period
    Trastuzumab Subcutaneously Then Trastuzumab Intravenously     Trastuzumab Intravenously Then Trastuzumab Subcutaneously     Cohort 1     Cohort 2  
STARTED     0 [1]   0 [1]   226 [2]   206 [2]
COMPLETED     0     0     226     119  
NOT COMPLETED     0     0     0     87  
[1] There were no participants in this reporting group in this period.
[2] Not all participants who completed crossover treatment 2 started the continuation period.

Period 4:   Safety Follow-up Period
    Trastuzumab Subcutaneously Then Trastuzumab Intravenously     Trastuzumab Intravenously Then Trastuzumab Subcutaneously     Cohort 1     Cohort 2  
STARTED     0 [1]   0 [1]   248 [2]   153 [3]
COMPLETED     0     0     22     12  
NOT COMPLETED     0     0     226     141  
[1] There were no participants in this reporting group in this period.
[2] All 248 randomized participants in Cohort 1 started the safety follow-up period.
[3] Some of the participants in Cohort 2 were still receiving treatment and did not start this period.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population: All participants who received at least 1 dose of trastuzumab.

Reporting Groups
  Description
Trastuzumab Subcutaneously and Intravenously Participants received trastuzumab on Day 1 of each 3-week cycle for 18 cycles. They either received trastuzumab 600 mg subcutaneously (SC) for 4 cycles followed by trastuzumab 6 mg/kg intravenously (IV) for 4 cycles or trastuzumab 6 mg/kg intravenously (IV) for 4 cycles followed by trastuzumab 600 mg subcutaneously (SC) for 4 cycles. For up to 10 remaining cycles, participants received either trastuzumab 6 mg/kg IV or trastuzumab 600 mg SC using the single-use injection device (Cohort 1) or trastuzumab 600 mg SC (Cohort 2).

Baseline Measures
    Trastuzumab Subcutaneously and Intravenously  
Number of Participants  
[units: participants]
  483  
Age  
[units: years]
Mean (Standard Deviation)
  53.1  (11.13)  
Gender  
[units: participants]
 
Female     483  
Male     0  



  Outcome Measures
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1.  Primary:   Participants’ Preferred Method of Drug Administration   [ Time Frame: Week 24 ]

2.  Secondary:   Healthcare Practitioners’ Most Satisfied Method of Drug Administration   [ Time Frame: Week 24 ]

3.  Secondary:   Healthcare Practitioners’ Perceived Time to Perform Each Method of Drug Administration   [ Time Frame: Week 24 ]

4.  Secondary:   Event-free Survival   [ Time Frame: Baseline to the end of the study (up to 3 years, 2 weeks) ]

5.  Secondary:   Participant Satisfaction With Subcutaneous Self-administration Using the Single-use Device   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01401166     History of Changes
Other Study ID Numbers: MO22982
Study First Received: July 22, 2011
Results First Received: February 9, 2015
Last Updated: June 3, 2015
Health Authority: Italy: Ministry of Health