ow-dose immunotherapy in addition to chemotherapy in patients with triple negative breast cancer
Phase 2
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2023/12/060529
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients who are diagnosed with triple negative breast cancer.
2. Patients who are planned to give NACT.
Exclusion Criteria
1. Patients who are not TNBC.
2. Patients who are not given NACT.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare pathological complete response with addition of low dose pembrolizumab in addition to NACT in patients with TNBCTimepoint: To compare pathological complete response with addition of low dose pembrolizumab in addition to NACT in patients with TNBC
- Secondary Outcome Measures
Name Time Method 1. To compare disease free survival in the two arms. <br/ ><br>2. Pharmacokinetics and pharmacodynamics of low dose pembrolizumab. <br/ ><br>3. PDL-1 IHC, genomic profile and tumor mutational burdenTimepoint: 5 Years