A Study in breast cancer patients to see how safe and effective is Dr. Reddy�s marketed drug Trastuzumab
Phase 4
Completed
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breast
- Registration Number
- CTRI/2019/01/017214
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1.Established histopathologically/cytologically confirmed diagnosis of HER2 positive breast cancer (early or metastatic) or metastatic gastric cancer with documented evidence of either IHC3+ or IHC2+ with fluorescence in situ hybridization (FISH) positivity;
2. Eligible to receive DRL_TZ treatment for EBC or MBC or MGC
Exclusion Criteria
1. Male patients with breast cancer
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety of DRL_TZ in patients with HER2-positive cancerTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy and immunogenicity of DRL_TZ in HER2-positive cancer patientsTimepoint: 6 months