Study of Immunotherapy in Triple negative breast cancer after surgery
Phase 3
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2024/02/062710
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients who sign informed consent.
2. Patients who have residual disease after NACT and Surgery.
Exclusion Criteria
1. Patients who have pathological complete response.
2. Patients who have contraindication of any Auto Immune Disorder.
3. Patients who have only DCIS present in their residual disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare invasive disease-free survival of patients with residual TNBC after NACT in two arms: a. Pembrolizumab and capecitabine b. CapecitabineTimepoint: 18 weeks.
- Secondary Outcome Measures
Name Time Method 1.To compare overall survival in the two-arms <br/ ><br>2. To assess the Quality of life and safety of the patients in the two-arms <br/ ><br>3.To assess the correlation of PDL1 expression by IHC, genomic profile and tumour mutational burden with response to low-dose pembrolizumab. <br/ ><br>Timepoint: 4 years