Pattern of treatment and outcomes in patients with recurrent and/or metastatic triple negative breast cancer - A single institute retrospective analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- To assess the treatment pattern and outcomes in patients with recurrent unresectable and/or metastatic triple negative breast cancers.
研究概览
简要总结
In India, there has been a steady increase in the incidence of breast cancer over the past decade. Breast cancer is the most common cancer among women in the urban Indian population. Around 15% of breast cancers do not express Estrogen Receptor (ER), Progesterone Receptor (PR) or Human Epidermal Growth Factor Receptor 2 (HER2) and are categorized as triple negative breast cancers (TNBC). TNBC’s show an aggressive clinical behavior and have a poor prognosis. Because of such aggressive behavior of this type of breast cancer there is an international interest in obtaining improvements in survival of these patients. Also, there is no specific guidelines available to treat metastatic TNBC. Considering the high incidence of the metastatic TNBC in India, its aggressive behavior and lack of essential data, especially in Indian settings, we propose to conduct this retrospective analysis to assess the treatment pattern and outcomes in patients with metastatic and/or recurrent TNBC. This result will form the base for future randomized control trials focusing on metastatic TNBC in India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All individuals above 18 years of age having histopathologically proven, recurrent and/or metastatic triple negative breast cancer (mTNBC) during the period of January 2015 to June
- •Patients could have received any number of lines of treatment in the metastatic and/or recurrent setting.
排除标准
- •Patients with breast cancer without triple negative disease.
结局指标
主要结局
To assess the treatment pattern and outcomes in patients with recurrent unresectable and/or metastatic triple negative breast cancers.
时间窗: 24 months
次要结局
- To assess the patterns of treatment used in the management of recurrent and/or metastatic TNBC.(24 months)
- To evaluate the OS in patients with recurrent and/or metastatic TNBC who are treated at the Tata Memorial Hospital and/or ACTREC during the study period.(24 months)
- To evaluate the PFS in patients with recurrent and/or metastatic TNBC who receive chemotherapy and/or Immunotherapy Targeted therapy during the mentioned study period at the Tata Memorial Hospital and/or ACTREC.(24 months)
- To assess the toxicity of treatment in included patients.(24 months)
- To assess the clinical and radiological profile in patients with metastatic TNBC.(24 months)