Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004499

Trial Description

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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 [SafeHer Study]

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and
tolerability 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 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 patients (Cohort B). Anticipated time on study treatment
is up to 1 year.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004499
  •   2012/11/30
  •   2012/03/22
  •   no
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Secondary IDs

  •   2011-005328-17 
  •   NCT01566721  (ClinicalTrials.gov)
  •   MO28048  (Hoffmann-La Roche)
  •   2011-005328-17 
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Health Condition or Problem studied

  •   Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Drug: trastuzumab [Herceptin]
  •   Drug: trastuzumab [Herceptin]
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Safety: Incidence of adverse events; time frame: approximately 8 years

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Secondary Outcome

- Disease-free survival; time frame: approximately 8 years
- Overall survival; time frame: approximately 8 years
- Patient satisfaction with trastuzumab SC using the single-use injection device (SID): SID satisfaction questionnaire (patients in cohort B who went on to self-administration of the study drug); time frame: approximately 3 years

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Countries of Recruitment

  •   Albania
  •   Algeria
  •   Argentina
  •   Australia
  •   Bosnia and Herzegovina
  •   Brazil
  •   Bulgaria
  •   Canada
  •   Chile
  •   Colombia
  •   Croatia
  •   Czech Republic
  •   Dominican Republic
  •   Ecuador
  •   Egypt
  •   El Salvador
  •   Finland
  •   France
  •   Germany
  •   Greece
  •   Guatemala
  •   Hong Kong
  •   Hungary
  •   India
  •   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, Province of China
  •   Thailand
  •   Turkey
  •   Ukraine
  •   United Arab Emirates
  •   United Kingdom
  •   Uruguay
  •   Venezuela, Bolivarian Republic of
  •   Viet Nam
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Locations of Recruitment

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Recruitment

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  •   2012/05/31
  •   2500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Adult male or female patients, >/= 18 years of age

- 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 adjuvant treatment with trastuzumab

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Screening left ventricular ejection fraction (LVEF) >/= 55%

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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 or basal cell carcinoma and patients with other curatively treated
malignancies, other than breast cancer, who have been disease-free for at least 5
years

- Past history of ductal carcinoma in situ that has been treated with any systemic
therapy or with radiation therapy to the ipsilateral breast where the invasive cancer
subsequently develops

- Metastatic disease

- Inadequate bone marrow, hepatic or renal function

- Serious cardiac or cardiovascular disease

- Uncontrolled hypertension, or history of hypertensive crisis or hypertensive
encephalopathy

- History of severe allergic or immunological reactions, e.g. difficult to control
asthma

- Pregnant or lactating women

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Reference Study ID Number: MO28048 www.roche.com/about_roche/roche_worldwide.htm 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.