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Clinical Trials/IRCT2015090621315N2
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Aryogene pharmed company

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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