A Study to Compare Subcutaneous Versus Intravenous Administration of Herceptin (Trastuzumab) in Women With HER2Positive Early Breast Cancer
Tracking Information
Start Date ICMJE | October 2009 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: July 30, 2009) |
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Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00950300 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 30, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study to Compare Subcutaneous Versus Intravenous Administration of Herceptin (Trastuzumab) in Women With HER2Positive Early Breast Cancer |
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Official Title ICMJE | A Randomized Open-label Study to Compare the Pharmacokinetics, Efficacy and Safety of Subcutaneous (SC) Herceptin (Trastuzumab) With Intravenous (IV) Herceptin (Traztuzumab) Administered in Women With HER2-positive Early Breast Cancer. |
Brief Summary | In this open-label multicenter trial patients with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery patients will receive a further 10 cycles of Herceptin SC or IV as per randomization to complete 1 year of treatment. Patients will be followed for up to 2 years after the end of treatment for safety and efficacy. Target sample size is >500. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Breast Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 552 | ||||
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Estimated Completion Date | October 2014 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Argentina, Brazil, Canada, Colombia, Costa Rica, Czech Republic, Ecuador, Estonia, France, Germany, Guatemala, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Mexico, Panama, Peru, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey |
Administrative Information
NCT ID ICMJE | NCT00950300 | ||||
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Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
Study ID Numbers ICMJE | BO22227, 2008-007326-19 | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche |
Source: http://clinicaltrials.gov/