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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)

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.
 
ClinicalTrials.gov Identifier: NCT01566721
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : April 18, 2017
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Herceptin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2577 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer
Actual Study Start Date : May 17, 2012
Actual Primary Completion Date : March 10, 2015
Actual Study Completion Date : February 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A: SC Herceptin by Needle/Syringe
Participants will receive SC Herceptin by an assisted administration using a conventional syringe and needle/vial formulation.
 Drug: Herceptin
Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
Other Name: Trastuzumab
Experimental: Cohort B: SC Herceptin by SID
Participants will receive SC Herceptin with assisted and/or self-administered use of an SID. The first administration will be performed by a trained healthcare professional. If well tolerated and the participant is willing and judged competent to perform self-administration, subsequent administration of SC Herceptin may be performed by the participant.
 Drug: Herceptin
Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
Other Name: Trastuzumab


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.

  2. 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) ]
    Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.

  3. 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) ]
    Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.

  4. Number of Herceptin Cycles Received [ Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) ]
    Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.

  5. 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) ]
    Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.

  6. Percentage of Participants Who Received Concomitant Cancer Therapy [ Time Frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years) ]
    Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.

  7. 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) ]
    Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.


Secondary Outcome Measures :
  1. 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) ]
    The percentage of participants who died from any cause was reported.

  2. Percentage of Participants Who Died During the Safety Follow-up Period [ Time Frame: From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years) ]
    The percentage of participants who died from any cause was reported during the safety follow-up period.

  3. Disease-Free Survival Rate [ Time Frame: From Baseline to time of event (up to approximately 8 years) ]

    DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.

    Time from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.


  4. Overall Survival Rate [ Time Frame: From Baseline to Time of Event (Up to Approximately 6 Years) ]

    Overall survival was defined as the time from randomization to death from any cause.

    Time from the date of randomization to the date of death was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.


  5. 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) ]
    The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from "Strongly Disagree" to "Strongly Agree". Questionnaire items were as follows: "I felt comfortable injecting the study drug by myself" (Comfortable), "The SID was convenient and easy to use" (Easy to Use), "I am confident giving myself an injection in the thigh with the SID" (Confident), "Taking all things into account I find self-administration using the SID satisfactory" (Satisfactory), "If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future" (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%

Exclusion Criteria:

  • Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
  • History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
  • Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
  • Metastatic disease
  • Inadequate bone marrow, hepatic, or renal function
  • Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
  • History of severe allergic or immunological reactions, such as difficult-to-control asthma
  • Pregnant or lactating women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566721


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
Study Protocol  [PDF] November 11, 2016
Statistical Analysis Plan  [PDF] February 20, 2020

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

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01566721    
Other Study ID Numbers: MO28048
2011-005328-17 ( EudraCT Number )
First Posted: March 29, 2012    Key Record Dates
Results First Posted: April 18, 2017
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents