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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01566721




Registration number
NCT01566721
Ethics application status
Date submitted
22/03/2012
Date registered
29/03/2012

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
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
Secondary ID [1] 0 0
2011-005328-17
Secondary ID [2] 0 0
MO28048
Universal Trial Number (UTN)
Trial acronym
SafeHER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
Timepoint [1] 0 0
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary outcome [2] 0 0
Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
Timepoint [2] 0 0
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary outcome [3] 0 0
Percentage of Participants With Treatment Interruption Due to an AE
Timepoint [3] 0 0
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary outcome [4] 0 0
Number of Herceptin Cycles Received
Timepoint [4] 0 0
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary outcome [5] 0 0
Percentage of Participants by Total Number of Herceptin Cycles Received
Timepoint [5] 0 0
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary outcome [6] 0 0
Percentage of Participants Who Received Concomitant Cancer Therapy
Timepoint [6] 0 0
From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Primary outcome [7] 0 0
Percentage of Participants Who Received Concomitant Non-Cancer Therapy
Timepoint [7] 0 0
From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Secondary outcome [1] 0 0
Percentage of Participants Who Died by Data Cutoff of 10 March 2015
Timepoint [1] 0 0
From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
Secondary outcome [2] 0 0
Percentage of Participants Who Died During the Safety Follow-up Period
Timepoint [2] 0 0
From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)
Secondary outcome [3] 0 0
Disease-Free Survival Rate
Timepoint [3] 0 0
From Baseline to time of event (up to approximately 8 years)
Secondary outcome [4] 0 0
Overall Survival Rate
Timepoint [4] 0 0
From Baseline to Time of Event (Up to Approximately 6 Years)
Secondary outcome [5] 0 0
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Timepoint [5] 0 0
Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)

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%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/02/2020
Sample size
Target
Accrual to date
Final
2577
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St George Hospital; Cancer Care Centre - Kogarah
Recruitment hospital [3] 0 0
Prince of Wales Hospital; Oncology - Randwick
Recruitment hospital [4] 0 0
Princess Alexandra Hospital; Division of Cancer Services - Woolloongabba
Recruitment hospital [5] 0 0
Queen Elizabeth Hospital; Medical Oncology - Woodville South
Recruitment hospital [6] 0 0
Western Hospital - Footscray
Recruitment hospital [7] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [8] 0 0
Cabrini Medical Centre; Oncology - Malvern
Recruitment hospital [9] 0 0
Royal Perth Hospital; Department of Medical Oncology - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
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Tirana
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Algeria
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Algiers
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Zarate
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??e?a?d???p???
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01566721