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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01566721
Registration number
NCT01566721
Ethics application status
Date submitted
22/03/2012
Date registered
29/03/2012
Date last updated
27/04/2021
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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2011-005328-17
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Secondary ID [2]
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MO28048
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Universal Trial Number (UTN)
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Trial acronym
SafeHER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Herceptin
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.
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.
Treatment: Drugs: Herceptin
Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
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Assessment method [1]
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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.
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Timepoint [1]
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From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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Primary outcome [2]
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Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
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Assessment method [2]
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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.
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Timepoint [2]
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From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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Primary outcome [3]
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Percentage of Participants With Treatment Interruption Due to an AE
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Assessment method [3]
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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.
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Timepoint [3]
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From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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Primary outcome [4]
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Number of Herceptin Cycles Received
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Assessment method [4]
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Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
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Timepoint [4]
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From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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Primary outcome [5]
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Percentage of Participants by Total Number of Herceptin Cycles Received
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Assessment method [5]
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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.
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Timepoint [5]
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From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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Primary outcome [6]
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Percentage of Participants Who Received Concomitant Cancer Therapy
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Assessment method [6]
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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.
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Timepoint [6]
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From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
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Primary outcome [7]
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Percentage of Participants Who Received Concomitant Non-Cancer Therapy
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Assessment method [7]
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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.
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Timepoint [7]
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From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
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Secondary outcome [1]
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Percentage of Participants Who Died by Data Cutoff of 10 March 2015
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Assessment method [1]
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The percentage of participants who died from any cause was reported.
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Timepoint [1]
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From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
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Secondary outcome [2]
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Percentage of Participants Who Died During the Safety Follow-up Period
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Assessment method [2]
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The percentage of participants who died from any cause was reported during the safety follow-up period.
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Timepoint [2]
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From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)
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Secondary outcome [3]
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Disease-Free Survival Rate
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Assessment method [3]
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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.
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Timepoint [3]
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From Baseline to time of event (up to approximately 8 years)
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Secondary outcome [4]
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Overall Survival Rate
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Assessment method [4]
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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.
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Timepoint [4]
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From Baseline to Time of Event (Up to Approximately 6 Years)
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Secondary outcome [5]
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Percentage of Participants by Item Response to SID Satisfaction Questionnaire
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Assessment method [5]
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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.
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Timepoint [5]
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Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)
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Eligibility
Key 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%
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/05/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/02/2020
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Sample size
Target
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Accrual to date
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Final
2577
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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St George Hospital; Cancer Care Centre - Kogarah
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Recruitment hospital [3]
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Prince of Wales Hospital; Oncology - Randwick
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Recruitment hospital [4]
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Princess Alexandra Hospital; Division of Cancer Services - Woolloongabba
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Recruitment hospital [5]
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Queen Elizabeth Hospital; Medical Oncology - Woodville South
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Recruitment hospital [6]
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Western Hospital - Footscray
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Recruitment hospital [7]
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Peninsula and South Eastern Haematology and Oncology Group - Frankston
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Recruitment hospital [8]
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Cabrini Medical Centre; Oncology - Malvern
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Recruitment hospital [9]
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Royal Perth Hospital; Department of Medical Oncology - Perth
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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5011 - Woodville South
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Recruitment postcode(s) [6]
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3011 - Footscray
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Recruitment postcode(s) [7]
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3199 - Frankston
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Recruitment postcode(s) [8]
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3144 - Malvern
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Recruitment postcode(s) [9]
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6000 - Perth
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Recruitment outside Australia
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Albania
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Tirana
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Algeria
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Zarate
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Bosnia and Herzegovina
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Banja Luka
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Bosnia and Herzegovina
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Sarajevo
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Brazil
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BA
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Brazil
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RS
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Brazil
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SP
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Bulgaria
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Plovdiv
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Sofia
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Heidelberg
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Jena
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Koeln
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Langen
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0
0
Mainz
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Marburg
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Meiningen
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Memmingen
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Minden
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Mühlhausen
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
München
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Münster
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Neuruppin
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Nürnberg
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Offenbach
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Ostfildern
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Recklinghausen
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Rotenburg/Wümme
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Saarbruecken
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Schweinfurt
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Schwerin
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Stendal
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Torgau
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Tübingen
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Unna
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Weinheim
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Weißenfels
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Wetzlar
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Wuerselen
Query!
Country [120]
0
0
Greece
Query!
State/province [120]
0
0
Athens
Query!
Country [121]
0
0
Greece
Query!
State/province [121]
0
0
Heraklion
Query!
Country [122]
0
0
Greece
Query!
State/province [122]
0
0
Kifisia
Query!
Country [123]
0
0
Greece
Query!
State/province [123]
0
0
Thessaloniki
Query!
Country [124]
0
0
Greece
Query!
State/province [124]
0
0
??e?a?d???p???
Query!
Country [125]
0
0
Greece
Query!
State/province [125]
0
0
?a??sa
Query!
Country [126]
0
0
Guatemala
Query!
State/province [126]
0
0
Guatemala City
Query!
Country [127]
0
0
Guatemala
Query!
State/province [127]
0
0
Guatemala
Query!
Country [128]
0
0
Hong Kong
Query!
State/province [128]
0
0
Hong Kong
Query!
Country [129]
0
0
Hong Kong
Query!
State/province [129]
0
0
Shatin
Query!
Country [130]
0
0
Hungary
Query!
State/province [130]
0
0
Budapest
Query!
Country [131]
0
0
Hungary
Query!
State/province [131]
0
0
Debrecen
Query!
Country [132]
0
0
Hungary
Query!
State/province [132]
0
0
Nyíregyháza
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
Pécs
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Szombathely
Query!
Country [135]
0
0
Indonesia
Query!
State/province [135]
0
0
Bandung
Query!
Country [136]
0
0
Indonesia
Query!
State/province [136]
0
0
Central Jakarta
Query!
Country [137]
0
0
Indonesia
Query!
State/province [137]
0
0
East Java
Query!
Country [138]
0
0
Indonesia
Query!
State/province [138]
0
0
Jakarta
Query!
Country [139]
0
0
Indonesia
Query!
State/province [139]
0
0
Jogjakarta
Query!
Country [140]
0
0
Ireland
Query!
State/province [140]
0
0
Dublin
Query!
Country [141]
0
0
Ireland
Query!
State/province [141]
0
0
Limerick City
Query!
Country [142]
0
0
Ireland
Query!
State/province [142]
0
0
Sligo
Query!
Country [143]
0
0
Ireland
Query!
State/province [143]
0
0
Waterford
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Basilicata
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Campania
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Emilia-Romagna
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Lazio
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Lombardia
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Piemonte
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Puglia
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Sardegna
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Sicilia
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Toscana
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Veneto
Query!
Country [155]
0
0
Korea, Republic of
Query!
State/province [155]
0
0
Goyang-si
Query!
Country [156]
0
0
Korea, Republic of
Query!
State/province [156]
0
0
Seoul
Query!
Country [157]
0
0
Lithuania
Query!
State/province [157]
0
0
Kaunas
Query!
Country [158]
0
0
Lithuania
Query!
State/province [158]
0
0
Klaipeda
Query!
Country [159]
0
0
Malaysia
Query!
State/province [159]
0
0
Georgetown
Query!
Country [160]
0
0
Malaysia
Query!
State/province [160]
0
0
Kuala Lumpur
Query!
Country [161]
0
0
Malaysia
Query!
State/province [161]
0
0
Sabah
Query!
Country [162]
0
0
Malaysia
Query!
State/province [162]
0
0
Sarawak
Query!
Country [163]
0
0
Mexico
Query!
State/province [163]
0
0
Campeche
Query!
Country [164]
0
0
Mexico
Query!
State/province [164]
0
0
Chihuahua
Query!
Country [165]
0
0
Mexico
Query!
State/province [165]
0
0
Distrito Federal
Query!
Country [166]
0
0
Mexico
Query!
State/province [166]
0
0
Mexico City
Query!
Country [167]
0
0
Mexico
Query!
State/province [167]
0
0
Oaxaca
Query!
Country [168]
0
0
Mexico
Query!
State/province [168]
0
0
Queretaro, Queretaro
Query!
Country [169]
0
0
Mexico
Query!
State/province [169]
0
0
Tepic
Query!
Country [170]
0
0
Morocco
Query!
State/province [170]
0
0
Rabat
Query!
Country [171]
0
0
Netherlands
Query!
State/province [171]
0
0
'S Hertogenbosch
Query!
Country [172]
0
0
Netherlands
Query!
State/province [172]
0
0
AC Amsterdam
Query!
Country [173]
0
0
Netherlands
Query!
State/province [173]
0
0
Apeldoorn
Query!
Country [174]
0
0
Netherlands
Query!
State/province [174]
0
0
Arnhem
Query!
Country [175]
0
0
Netherlands
Query!
State/province [175]
0
0
Dordrecht
Query!
Country [176]
0
0
Netherlands
Query!
State/province [176]
0
0
EDE
Query!
Country [177]
0
0
Netherlands
Query!
State/province [177]
0
0
Eindhoven
Query!
Country [178]
0
0
Netherlands
Query!
State/province [178]
0
0
Groningen
Query!
Country [179]
0
0
Netherlands
Query!
State/province [179]
0
0
Heerlen
Query!
Country [180]
0
0
Netherlands
Query!
State/province [180]
0
0
Hoofddorp
Query!
Country [181]
0
0
Netherlands
Query!
State/province [181]
0
0
Nieuwegein
Query!
Country [182]
0
0
Netherlands
Query!
State/province [182]
0
0
Roosendaal
Query!
Country [183]
0
0
Netherlands
Query!
State/province [183]
0
0
Rotterdam
Query!
Country [184]
0
0
Netherlands
Query!
State/province [184]
0
0
Schiedam
Query!
Country [185]
0
0
Netherlands
Query!
State/province [185]
0
0
Sittard-Geleen
Query!
Country [186]
0
0
Netherlands
Query!
State/province [186]
0
0
Utrecht
Query!
Country [187]
0
0
Netherlands
Query!
State/province [187]
0
0
Venlo
Query!
Country [188]
0
0
Netherlands
Query!
State/province [188]
0
0
Zaandam
Query!
Country [189]
0
0
New Zealand
Query!
State/province [189]
0
0
Tauranga
Query!
Country [190]
0
0
Norway
Query!
State/province [190]
0
0
Kristiansand
Query!
Country [191]
0
0
Norway
Query!
State/province [191]
0
0
Oslo
Query!
Country [192]
0
0
Norway
Query!
State/province [192]
0
0
Stavanger
Query!
Country [193]
0
0
Pakistan
Query!
State/province [193]
0
0
Islamabad
Query!
Country [194]
0
0
Pakistan
Query!
State/province [194]
0
0
Karachi
Query!
Country [195]
0
0
Pakistan
Query!
State/province [195]
0
0
Lahore
Query!
Country [196]
0
0
Panama
Query!
State/province [196]
0
0
Panama
Query!
Country [197]
0
0
Peru
Query!
State/province [197]
0
0
Arequipa
Query!
Country [198]
0
0
Peru
Query!
State/province [198]
0
0
Lima
Query!
Country [199]
0
0
Peru
Query!
State/province [199]
0
0
LIma
Query!
Country [200]
0
0
Philippines
Query!
State/province [200]
0
0
Manila
Query!
Country [201]
0
0
Philippines
Query!
State/province [201]
0
0
Quezon City
Query!
Country [202]
0
0
Poland
Query!
State/province [202]
0
0
Kraków
Query!
Country [203]
0
0
Poland
Query!
State/province [203]
0
0
Otwock
Query!
Country [204]
0
0
Poland
Query!
State/province [204]
0
0
Poznan
Query!
Country [205]
0
0
Poland
Query!
State/province [205]
0
0
Rzeszow
Query!
Country [206]
0
0
Poland
Query!
State/province [206]
0
0
Torun
Query!
Country [207]
0
0
Poland
Query!
State/province [207]
0
0
Zory
Query!
Country [208]
0
0
Portugal
Query!
State/province [208]
0
0
Lisboa
Query!
Country [209]
0
0
Portugal
Query!
State/province [209]
0
0
Porto
Query!
Country [210]
0
0
Romania
Query!
State/province [210]
0
0
Baia Mare
Query!
Country [211]
0
0
Romania
Query!
State/province [211]
0
0
Bucharest
Query!
Country [212]
0
0
Romania
Query!
State/province [212]
0
0
Bucuresti
Query!
Country [213]
0
0
Romania
Query!
State/province [213]
0
0
Cluj Napoca
Query!
Country [214]
0
0
Romania
Query!
State/province [214]
0
0
Cluj-Napoca
Query!
Country [215]
0
0
Romania
Query!
State/province [215]
0
0
Craiova
Query!
Country [216]
0
0
Romania
Query!
State/province [216]
0
0
Timisoara
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Irkutsk
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Izhevsk
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Moscow
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Orenburg
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
Saint-Petersburg
Query!
Country [222]
0
0
Russian Federation
Query!
State/province [222]
0
0
UFA
Query!
Country [223]
0
0
Saudi Arabia
Query!
State/province [223]
0
0
Jeddah
Query!
Country [224]
0
0
Saudi Arabia
Query!
State/province [224]
0
0
Riyadh
Query!
Country [225]
0
0
Serbia
Query!
State/province [225]
0
0
Belgrade
Query!
Country [226]
0
0
Serbia
Query!
State/province [226]
0
0
Kragujevac
Query!
Country [227]
0
0
Serbia
Query!
State/province [227]
0
0
Nis
Query!
Country [228]
0
0
Serbia
Query!
State/province [228]
0
0
Sremska Kamenica
Query!
Country [229]
0
0
Singapore
Query!
State/province [229]
0
0
Singapore
Query!
Country [230]
0
0
Slovakia
Query!
State/province [230]
0
0
Banská Bystrica
Query!
Country [231]
0
0
Slovakia
Query!
State/province [231]
0
0
Bratislava
Query!
Country [232]
0
0
Slovakia
Query!
State/province [232]
0
0
Košice
Query!
Country [233]
0
0
Slovakia
Query!
State/province [233]
0
0
Presov
Query!
Country [234]
0
0
Slovakia
Query!
State/province [234]
0
0
Trencin
Query!
Country [235]
0
0
Slovenia
Query!
State/province [235]
0
0
Maribor
Query!
Country [236]
0
0
South Africa
Query!
State/province [236]
0
0
Durban
Query!
Country [237]
0
0
South Africa
Query!
State/province [237]
0
0
Johannesburg
Query!
Country [238]
0
0
South Africa
Query!
State/province [238]
0
0
Pretoria
Query!
Country [239]
0
0
Spain
Query!
State/province [239]
0
0
Alicante
Query!
Country [240]
0
0
Spain
Query!
State/province [240]
0
0
Asturias
Query!
Country [241]
0
0
Spain
Query!
State/province [241]
0
0
Barcelona
Query!
Country [242]
0
0
Spain
Query!
State/province [242]
0
0
Cantabria
Query!
Country [243]
0
0
Spain
Query!
State/province [243]
0
0
Guipuzcoa
Query!
Country [244]
0
0
Spain
Query!
State/province [244]
0
0
Islas Baleares
Query!
Country [245]
0
0
Spain
Query!
State/province [245]
0
0
LAS Palmas
Query!
Country [246]
0
0
Spain
Query!
State/province [246]
0
0
Madrid
Query!
Country [247]
0
0
Spain
Query!
State/province [247]
0
0
Pontevedra
Query!
Country [248]
0
0
Spain
Query!
State/province [248]
0
0
Tenerife
Query!
Country [249]
0
0
Spain
Query!
State/province [249]
0
0
Valencia
Query!
Country [250]
0
0
Spain
Query!
State/province [250]
0
0
Vizcaya
Query!
Country [251]
0
0
Spain
Query!
State/province [251]
0
0
Albacete
Query!
Country [252]
0
0
Spain
Query!
State/province [252]
0
0
Burgos
Query!
Country [253]
0
0
Spain
Query!
State/province [253]
0
0
Caceres
Query!
Country [254]
0
0
Spain
Query!
State/province [254]
0
0
Jaen
Query!
Country [255]
0
0
Spain
Query!
State/province [255]
0
0
Leon
Query!
Country [256]
0
0
Spain
Query!
State/province [256]
0
0
Lerida
Query!
Country [257]
0
0
Spain
Query!
State/province [257]
0
0
Murcia
Query!
Country [258]
0
0
Spain
Query!
State/province [258]
0
0
Navarra
Query!
Country [259]
0
0
Spain
Query!
State/province [259]
0
0
Toledo
Query!
Country [260]
0
0
Spain
Query!
State/province [260]
0
0
Zaragoza
Query!
Country [261]
0
0
Sweden
Query!
State/province [261]
0
0
Lund
Query!
Country [262]
0
0
Sweden
Query!
State/province [262]
0
0
Skoevde
Query!
Country [263]
0
0
Switzerland
Query!
State/province [263]
0
0
Aarau
Query!
Country [264]
0
0
Switzerland
Query!
State/province [264]
0
0
Baden
Query!
Country [265]
0
0
Switzerland
Query!
State/province [265]
0
0
Bellinzona
Query!
Country [266]
0
0
Switzerland
Query!
State/province [266]
0
0
Bern
Query!
Country [267]
0
0
Switzerland
Query!
State/province [267]
0
0
Frauenfeld
Query!
Country [268]
0
0
Switzerland
Query!
State/province [268]
0
0
Lausanne
Query!
Country [269]
0
0
Switzerland
Query!
State/province [269]
0
0
Thun
Query!
Country [270]
0
0
Switzerland
Query!
State/province [270]
0
0
Winterthur
Query!
Country [271]
0
0
Switzerland
Query!
State/province [271]
0
0
Zürich
Query!
Country [272]
0
0
Taiwan
Query!
State/province [272]
0
0
Taichung
Query!
Country [273]
0
0
Taiwan
Query!
State/province [273]
0
0
Tainan
Query!
Country [274]
0
0
Taiwan
Query!
State/province [274]
0
0
Taipei
Query!
Country [275]
0
0
Thailand
Query!
State/province [275]
0
0
Bangkok
Query!
Country [276]
0
0
Thailand
Query!
State/province [276]
0
0
Chiang Mai
Query!
Country [277]
0
0
Thailand
Query!
State/province [277]
0
0
Dusit
Query!
Country [278]
0
0
Turkey
Query!
State/province [278]
0
0
Ankara
Query!
Country [279]
0
0
Turkey
Query!
State/province [279]
0
0
Antalya
Query!
Country [280]
0
0
Turkey
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Funding & Sponsors
Primary sponsor type
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Name
Hoffmann-La Roche
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01566721
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01566721
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