IRCT2015090621315N2
Completed
Phase 3
A randomized, double blind clinical trial to evaluate biosafety of trastuzumab produced by aryogen company (™Hercease) in comparison to Roche company trastuzumab (™Herceptin)
Aryogene pharmed company0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Benign neoplasm of breast.
- Sponsor
- Aryogene pharmed company
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •inclusion criteria: female aged 18\- 70 years at the time of signing the informed consent form; HER2\+ breast cancer in ich experiment with 3\+ and or 2\+ that has reported positive by FISH method; ECOG grade between 0\-1; LVEF 55% or more.
- •exclusion criteria: bilateral metastatic breast cancer; other malignancies; renal, liver, bone marrow and cardiac insufficiencies; hypertention; pregnancy or planning to be pregnant.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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