Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: -Histologically confirmed diagnosis of triple negative breast cancer. -Estrogen receptor expression less than 1 percent. -Progesterone receptor expression less than 1 percent. -Human epidermal growth factor receptor 2 negative status defined as immunohistochemistry score 0 or 1 plus, or immunohistochemistry score 2 plus with negative fluorescence in situ hybridization. -Received at least one dose of pembrolizumab as part of the treatment regimen in either the neoadjuvant or adjuvant setting for early stage triple negative breast cancer, or in the first line or subsequent lines of therapy for metastatic triple negative breast cancer. -Programmed death ligand 1 expression tested and documented where available, for example combined positive score using Dako 22C3 or an equivalent assay. -Availability of baseline clinical data including staging and treatment plan, and a minimum of one post treatment response assessment or follow up evaluation. -Treated at TMH or ACTREC between January 1 2023 and September 30 2025.
Exclusion criteria
Exclusion criteria: -Participation in blinded or placebo controlled interventional clinical trials during pembrolizumab therapy. -Patients with incomplete or missing essential clinical or treatment records, including survival or response outcomes. -Presence of active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years, excluding physiologic replacement such as thyroiditis. -Concurrent active malignancies, except for adequately treated non melanoma skin cancer or in situ cervical carcinoma. -Known untreated or symptomatic central nervous system metastases at the time of pembrolizumab initiation. -Prior treatment with other immune checkpoint inhibitors such as nivolumab or atezolizumab, unless pembrolizumab is being administered in a subsequent line due to intolerance or disease progression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Progression-Free Survival: The time from the initiation of pembrolizumab-based therapy to the first occurrence of disease progression or death from any cause, whichever occurs first. 2 Overall Survival: Time from the initiation of therapy to death from any cause. 3 Pathological Complete Response: For early-stage TNBC patients receiving neoadjuvant pembrolizumab: pCR is defined as no residual invasive cancer in the breast and lymph nodes ypT0 or Tis ypN0 at the time of surgery. Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Free Survival Time from date of diagnosis to first recurrence local or distant or death from any cause Objective Response Rate Proportion of patients achieving complete or partial response as per RECIST version 1 point 1 in metastatic disease Safety and Tolerability Incidence and severity of adverse events including immune related adverse events graded by CTCAE version 5 point 0 Treatment Discontinuation Rate Proportion of patients discontinuing pembrolizumab due to toxicity financial constraints or disease progression Biomarker Association Correlation of PD L1 expression with clinical outcomes including progression free survival overall survival and objective response rateTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactAnbarasan Sekar
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre
Outcome results
None listed