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A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (SafeHER)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01566721
First received: March 22, 2012
Last updated: March 6, 2017
Last verified: March 2017
Results First Received: March 6, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Intervention: Drug: Herceptin

  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
Of the 2984 participants screened, a total of 2577 participants were enrolled into the trial, and 2573 participants received at least one dose of study treatment.

Reporting Groups
  Description
Cohort A: SC Herceptin by Needle/Syringe Participants received SC Herceptin by an assisted administration as 600 milligrams (mg) every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Cohort B: SC Herceptin by Single-Use Injection Device (SID) Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by a healthcare professional (HCP). Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Participant Flow:   Overall Study
    Cohort A: SC Herceptin by Needle/Syringe   Cohort B: SC Herceptin by Single-Use Injection Device (SID)
STARTED   1867   710 
Received Treatment   1864   709 
COMPLETED   0   0 
NOT COMPLETED   1867   710 
Ongoing Study                1649                659 
Withdrawal by Subject                58                15 
Disease Progression/Recurrence                123                28 
Lost to Follow-up                18                0 
Death                6                3 
Not Specified                10                4 
Withdrew Prior to Treatment                3                1 



  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.
Intent-to-Treat (ITT) Population: All participants enrolled into the study regardless of whether treatment was received.

Reporting Groups
  Description
Cohort A: SC Herceptin by Needle/Syringe Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Cohort B: SC Herceptin by SID Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Total Total of all reporting groups

Baseline Measures
   Cohort A: SC Herceptin by Needle/Syringe   Cohort B: SC Herceptin by SID   Total 
Overall Participants Analyzed 
[Units: Participants]
 1867   710   2577 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.0  (12.01)   53.0  (11.32)   53.7  (11.83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1863  99.8%      710 100.0%      2573  99.8% 
Male      4   0.2%      0   0.0%      4   0.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period   [ Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) ]

2.  Primary:   Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period   [ Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) ]

3.  Primary:   Percentage of Participants With Treatment Interruption Due to an AE   [ Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) ]

4.  Primary:   Number of Herceptin Cycles Received   [ Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) ]

5.  Primary:   Percentage of Participants by Total Number of Herceptin Cycles Received   [ Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) ]

6.  Primary:   Percentage of Participants Who Received Concomitant Cancer Therapy   [ Time Frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years) ]

7.  Primary:   Percentage of Participants Who Received Concomitant Non-Cancer Therapy   [ Time Frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years) ]

8.  Secondary:   Percentage of Participants Who Died by Data Cutoff of 10 March 2015   [ Time Frame: From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015) ]

9.  Secondary:   Percentage of Participants by Item Response to SID Satisfaction Questionnaire   [ Time Frame: Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year) ]

10.  Secondary:   Disease-Free Survival (DFS)   [ Time Frame: From Baseline to time of event (up to approximately 8 years) ]
Results not yet reported.   Anticipated Reporting Date:   2020  

11.  Secondary:   Overall Survival (OS)   [ Time Frame: From Baseline to time of event (up to approximately 8 years) ]
Results not yet reported.   Anticipated Reporting Date:   2020  


  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: global-roche-genentech-trials@gene.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01566721     History of Changes
Other Study ID Numbers: MO28048
2011-005328-17 ( EudraCT Number )
Study First Received: March 22, 2012
Results First Received: March 6, 2017
Last Updated: March 6, 2017