To evaluate safety and efficacy of Trastuzumab, (Manufactured by Intas) in comparison with Reference Biologic (Trastuzumab, Marketed by Roche) in the patients with Metastatic Breast Cancer.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2015/09/006168
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1.The patient willing to give informed consent to participate in the study before initiating any study related procedures
2.Female >=18 years and <=65 years of age at screening.
3.Women with histologically/cytologically confirmed HER2 (human epidermal growth factor receptor 2)-Overexpressing metastatic breast cancer.
4.Patients who are eligible for taxanes and Trastuzumab as per opinion of PI.
5.Patient must have an adequate bone marrow, renal, cardiac and hepatic function.
1.Patient with severely immunocompromised state.
2.Chronic treatment with systemic steroids or another immunosuppressive agent.
3.Clinically significant medical condition that, in opinion of the investigator, might place the patient at unacceptable risk for participation in this study
4.Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections).
5.Any malignancy in the last 2 years other than breast cancer except skin cancer or carcinoma in situ of the cervix
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method