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Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer (PrefHER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401166
First Posted: July 25, 2011
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: February 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Breast Neoplasms
Interventions: Drug: Herceptin
Device: Single-Use Injection Device

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 248 participants were randomized into the study in Cohort 1 (of whom 244 were treated) and 240 participants were randomized into the study in Cohort 2 (of whom 239 were treated). Those participants who did not receive any treatment were not included in the treatment periods of the Participant Flow.

Reporting Groups
  Description
Cohort 1: SC (SID) Then IV Herceptin Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by healthcare professional (HCP). Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 milligrams (mg) for all cycles where SC Herceptin was given, and the IV dose was 6 milligrams per kilogram (mg/kg) for all cycles where IV Herceptin was given.
Cohort 1: IV Then SC (SID) Herceptin Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
Cohort 2: SC (Vial) Then IV Herceptin Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
Cohort 2: IV Then SC (Vial) Herceptin Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.

Participant Flow for 4 periods

Period 1:   Crossover Treatment 1 (Cycles 1 to 4)
    Cohort 1: SC (SID) Then IV Herceptin   Cohort 1: IV Then SC (SID) Herceptin   Cohort 2: SC (Vial) Then IV Herceptin   Cohort 2: IV Then SC (Vial) Herceptin
STARTED   122 [1]   122 [1]   121 [2]   118 [3] 
COMPLETED   119   120   119   116 
NOT COMPLETED   3   2   2   2 
[1] A total of 124 participants were randomized, but 2 did not receive any treatment.
[2] A total of 121 participants were randomized who all received study treatment.
[3] A total of 119 participants were randomized, but 1 did not receive any treatment.

Period 2:   Crossover Treatment 2 (Cycles 5 to 8)
    Cohort 1: SC (SID) Then IV Herceptin   Cohort 1: IV Then SC (SID) Herceptin   Cohort 2: SC (Vial) Then IV Herceptin   Cohort 2: IV Then SC (Vial) Herceptin
STARTED   119   120   119   116 
COMPLETED   113   116   107   105 
NOT COMPLETED   6   4   12   11 

Period 3:   Continuation Treatment (Cycles 9 to 18)
    Cohort 1: SC (SID) Then IV Herceptin   Cohort 1: IV Then SC (SID) Herceptin   Cohort 2: SC (Vial) Then IV Herceptin   Cohort 2: IV Then SC (Vial) Herceptin
STARTED   113   116   107   105 
COMPLETED   109   109   105   102 
NOT COMPLETED   4   7   2   3 

Period 4:   Safety Follow-Up Period
    Cohort 1: SC (SID) Then IV Herceptin   Cohort 1: IV Then SC (SID) Herceptin   Cohort 2: SC (Vial) Then IV Herceptin   Cohort 2: IV Then SC (Vial) Herceptin
STARTED   124 [1]   124 [1]   121 [2]   119 [3] 
COMPLETED   99   106   104   100 
NOT COMPLETED   25   18   17   19 
[1] All 124 randomized participants entered follow-up regardless of whether they received treatment.
[2] All 121 randomized participants entered follow-up regardless of whether they received treatment.
[3] All 119 randomized participants entered follow-up regardless of whether they received treatment.



  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 one dose of Herceptin.

Reporting Groups
  Description
Cohort 1 Overall: SC (SID) and IV Herceptin Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
Cohort 2 Overall: SC (Vial) and IV Herceptin Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
Total Total of all reporting groups

Baseline Measures
   Cohort 1 Overall: SC (SID) and IV Herceptin   Cohort 2 Overall: SC (Vial) and IV Herceptin   Total 
Overall Participants Analyzed 
[Units: Participants]
 244   239   483 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.3  (11.40)   52.9  (10.87)   53.1  (11.13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      244 100.0%      239 100.0%      483 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants by Preferred Method of Drug Administration   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of HCPs by Most Satisfied Method of Drug Administration   [ Time Frame: Week 24 ]

3.  Secondary:   Percentage of HCPs by Time Required to Perform Each Method of Drug Administration   [ Time Frame: Week 24 ]

4.  Secondary:   Percentage of Participants With an Event-Free Survival (EFS) Event   [ Time Frame: From Baseline until time of event; assessed every 6 months (median follow-up of 3 years) ]

5.  Secondary:   Duration of EFS According to Kaplan-Meier Estimate   [ Time Frame: From Baseline until time of event; assessed every 6 months (median follow-up of 3 years) ]

6.  Secondary:   3-Year EFS Rate   [ Time Frame: Year 3 ]

7.  Secondary:   Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire   [ Time Frame: Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52) ]

8.  Secondary:   Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies   [ Time Frame: Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks) ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01401166     History of Changes
Other Study ID Numbers: MO22982
2010-024099-25 ( EudraCT Number )
First Submitted: July 22, 2011
First Posted: July 25, 2011
Results First Submitted: February 9, 2015
Results First Posted: June 8, 2015
Last Update Posted: March 6, 2017