A Study of Trastuzumab Subcutaneous in Participants With Human Epidermal Growth Factor Receptor-2 (HER2) Positive Early Breast Cancer
NCT ID: NCT01959386
Last Updated: 2020-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1006 participants
OBSERVATIONAL
2013-11-07
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HER2 Positive Breast Cancer Participants
Participants with HER2 positive tumors who are considered for treatment with trastuzumab SC according to the judgement of physician and according to the actual summary of product characteristics will be observed for a period of approximately 1 year and will be followed for an additional 2 years.
Trastuzumab
Participants will be receiving trastuzumab as part of their treatment for breast cancer according to the judgement of physician and according to the actual summary of product characteristics. The study protocol does not influence the physician's decision regarding diagnostics, therapy or frequency of medical examination during or after the treatment.
Interventions
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Trastuzumab
Participants will be receiving trastuzumab as part of their treatment for breast cancer according to the judgement of physician and according to the actual summary of product characteristics. The study protocol does not influence the physician's decision regarding diagnostics, therapy or frequency of medical examination during or after the treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HER2-positive tumor
* Eligible for neo-adjuvant or adjuvant treatment with trastuzumab SC according to the judgement of the physician Note: As of participant recruitment (date of participant informed consent), retrospective documentation is allowed but limited to up to 9 weeks after initial start of therapy with trastuzumab SC
Exclusion Criteria
* Pregnant and breastfeeding women
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, , Germany
Countries
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Other Identifiers
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ML28759
Identifier Type: -
Identifier Source: org_study_id
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