A Clinical Study to evaluate the Effectiveness and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension in comparison with Taxol in Breast cancer patients.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2015/07/006062
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
1.The patient willing to give written, signed and dated, informed consent to participate in the study before initiating any study related procedures
2.Patient must have histopathologically /cytologically confirmed breast cancer
3.Have at least one measurable lesion as per the RECIST criteria (Version 1.1)
4.Patients with life expectancy of at least 6 months.
5.Patient must have negative serum pregnancy test at screening
1.Patient who has already exposed to Taxane Injection
2.Any of the following cardiac conditions:
•Unstable angina
•Myocardial infarction within the past 6 months
•Severe uncontrolled ventricular arrhythmias
•Clinically significant pericardial disease
•Electrocardiographic evidence of acute ischemia or active conduction system abnormality
•History of cardiac disease that met the NYHA Classification class 2 or greater
3.Known history of drug addiction within last 1 year
4.Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method