Real World Data on Pembrolizumab in Triple-Negative Breast Cancer Patients – A Retrospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
Triple-negative breast cancer (TNBC) is one of the most aggressive and hard-to-treat types of breast cancer. It doesn’t respond to common treatments like hormone therapy or HER2-targeted drugs. Pembrolizumab is a medicine that helps the body’s immune system fight cancer. It has been approved for use in several cancers, including TNBC, based on results from international studies. However, these studies usually take place in highly controlled environments and may not show how the treatment works in real-life hospitals, especially in countries like India, where access to advanced treatments can be limited. This study will look back at the medical records of patients with early-stage or advanced TNBC who were treated with pembrolizumab at Tata Memorial Hospital (TMH) and ACTREC between January 1, 2023, and September 30, 2025. The goal is to understand how long patients lived after treatment and how long they stayed without the disease getting worse. The study will also look at how well the treatment worked and whether patients experienced any side effects. It will also check how well the usual treatment worked in these patients. The findings will help doctors understand how well pembrolizumab works for TNBC patients in India and how to use it better. It may also point out areas where patient care can be improved.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
- •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.
研究者
Anbarasan Sekar
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre