A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer
Completed
- Conditions
- Breast Cancer, Early Breast Cancer
- Interventions
- Other: No intervention
- Registration Number
- NCT02443467
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 211
Inclusion Criteria
- Female patients > or = 18 years of age
- Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression
- Previously treated with adjuvant antracycline containing chemotherapy
- Left Ventricular Ejection Fraction (LVEF) > 50%
- Eastern Cooperative Oncology Group (ECOG) score < or = 2
- Life expectancy > or = 12 weeks
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Exclusion Criteria
- Left Ventricular Ejection Fraction (LVEF) < 50%
- Advanced pulmonary disease
- Severe dyspnea
- Abnormal laboratory results within 14 days prior to registration
- Peripheral neuropathy
- Presence of Central Nervous System (CNS) metastasis
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HER2-positive early breast cancer No intervention Human Epidermal Growth Factor Receptor 2 (HER2)-positive early breast cancer treated with loading dose of Herceptin (trastuzumab) administered as 6 mg/kg followed by once in 3 weeks administration at 4 mg/kg up to 12 months of treatment
- Primary Outcome Measures
Name Time Method Percentage of participants with adverse events Up to 3 years Percentage of participants with serious adverse events Up to 3 years
- Secondary Outcome Measures
Name Time Method