Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Pembrolizumab: Standard chemotherapy with low dose pembrolizumab 50 mg every 6 weeks.
Intervention2: Pembrolizumab with Capecitabine: 4 cycles of pembrolizumab 50mg flat dose infusion e
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who sign informed consent. 2. Patients who have residual disease after NACT and Surgery.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. To compare overall survival in the two-arms 2. To assess the Quality of life and safety of the patients in the two-arms 3. To assess the correlation of PDL1 expression by IHC, genomic profile and tumour mutational burden with response to low-dose pembrolizumab. Timepoint: 4 years | — |
Countries
India
Contacts
Public ContactDr Atul Batra
Dr. B. R. Ambedkar, Institute Rotary Cancer Hospital
Outcome results
None listed