To find Natural killers cells as a treatment option for Triple negative breast cancer.
Not Applicable
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2023/10/058292
- Lead Sponsor
- Tata Memorial Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult Patients with early-stage breast cancer undergoing biopsy if age less than 50 years.
Adult Patients 18-65 years of age with metastatic breast cancer that is histologically proven to be
triple negative.
Adult Patients with early-stage breast cancer undergoing biopsy if age less than 50 years.
Exclusion Criteria
1. Patients with hormone receptor positive or HER 2 positive breast cancer
2. Patients who had received two or more lines of chemotherapy in
metastatic setting
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To study the expression of CD1d in commercially available TNBC cell lines, TNBC <br/ ><br>patient tumour sections from early untreated, post-chemotherapy treated & metastatic <br/ ><br>patients. <br/ ><br>2. To study the anti-tumor activity of invariant natural killer T (iNKT) cells, first in <br/ ><br>preclinical TNBC cell lines, patient derived cell lines & then in animal xenograft <br/ ><br>model. <br/ ><br>3. To produce peripheral monocyte-derived APCs & ex-vivo expanded iNKT cells in a <br/ ><br>cellular GMP facility. <br/ ><br>. To prepare a Clinical Trial for evaluation of the safety and feasibility of iNKT cell <br/ ><br>infusion in metastatic triple negative breast cancer patients.Timepoint: 3 years
- Secondary Outcome Measures
Name Time Method Preparation of activated iNKT cells from peripheral bloodTimepoint: 3 years