SafeHer
Registration number(s): 
Summary of trial and patient characteristics
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Recruitment status
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Recruiting
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Trial start date
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5 Jul 2012
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Trial end date
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Sex
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Female and Male
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Age range
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18 to 75 years
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| |
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Breast cancer type
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Ductal Carcinoma in Situ (DCIS)
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Stage
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Localised
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Surgical treatment
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Breast surgery already performed
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Oestrogen receptor status
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Not applicable
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Progesterone receptor status
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Not applicable
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HER 2 status
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HER 2 positive
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Gene carrier
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Unknown
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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 ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE EARLY BREAST CANCER
Trial summary
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and efficacy of assisted- and self-administered subcutaneous Herceptin (trastuzumab) as adjuvant therapy in patients with early HER2-positive breast cancer whose tumour has been excised. Patients will receive Herceptin 600 mg subcutaneously every 3 weeks for 18 cycles, either by assisted administration (Cohort A) or self-administered by Single-use Injection Device (Cohort B). Anticipated time on study treatment is up to 1 year.
General information about this or other trials
trialslink@cancervic.org.au
Trial sponsor
Hoffmann-La Roche
Participating hospitals
| Hospital | Suburb / Town | Contact name | Email | Phone | Recruitment status |
|
Cabrini Hospital
|
Malvern
|
Ms Barbara Scher
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bscher@cabrini.com.au
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03 9508 1669
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Recruiting
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Murray Valley Private Hospital
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Wodonga
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Ms Julie Croft
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jcroft@bordermedonc.com.au
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02 6051 5325
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Recruiting
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Peninsula Oncology Centre
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Frankston
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Mr Albert Goikman
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albert@poc.com.au
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03 9771 8909
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Recruiting
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Western Hospital
|
Footscray
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Ms Helen Brasier
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helen.brasier@wh.org.au
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03 8345 7609
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Recruiting
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