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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 : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 29, 2012
Results First Submitted Date  ICMJE March 6, 2017
Results First Posted Date  ICMJE April 18, 2017
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE May 17, 2012
Actual Primary Completion Date March 10, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
Safety: Incidence of adverse events [ Time Frame: approximately 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
  • Disease-Free Survival (DFS) [ 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.
  • 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.
  • Overall Survival (OS) [ Time Frame: From Baseline to time of event (up to approximately 8 years) ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • Disease-free survival (recurrence assessed according to ASCO 2006 Guideline for Breast Cancer Follow-up) [ Time Frame: approximately 5 years ]
  • Overall survival [ Time Frame: approximately 5 years ]
  • Patient satisfaction with trastuzumab SC single use injection device (SID): SID Satisfaction Questionnaire (cohort B only) [ Time Frame: approximately 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Herceptin
  • 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.
    Intervention: Drug: Herceptin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2017)
2577
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2012)
2500
Actual Study Completion Date  ICMJE February 19, 2020
Actual Primary Completion Date March 10, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Albania,   Algeria,   Argentina,   Australia,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czechia,   Dominican Republic,   Ecuador,   Egypt,   El Salvador,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   Hungary,   Indonesia,   Ireland,   Italy,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   Morocco,   Netherlands,   New Zealand,   Norway,   Pakistan,   Panama,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Singapore,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Arab Emirates,   United Kingdom,   Uruguay,   Venezuela,   Vietnam
Removed Location Countries Czech Republic,   Finland,   India
 
Administrative Information
NCT Number  ICMJE NCT01566721
Other Study ID Numbers  ICMJE MO28048
2011-005328-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP