Comparative analysis of trastuzumab(Aryogen) with Herceptin®
Phase 3
- Conditions
- breast cancer.Malignant neoplasm of breast
- Registration Number
- IRCT201208116302N4
- Lead Sponsor
- AryoGen Biopharma Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
older than 18 years; HER2 positive (3+) in IHC test or (2+) with positive FISH test; size of tumor more than 2cm; ECOG grade between 0-1; LVEF more than 55%; complete inform consent form
Exclusion criteria:metastatic breast cancer; bilaterally breast cancer; other neoplasms; bone marrow failure; renal failure; liver failure; heart failure; uncontroled hypertension; pregnancy during study or planning for pregnancy at the beginning of study. .
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological response of breast tumor according to sataloff criteria. Timepoint: 18 weeks after beginning of neoadjuvant therapy. Method of measurement: pathological evaluation of breast biopsy by pathologist.
- Secondary Outcome Measures
Name Time Method