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临床试验/CTRI/2024/01/061744
CTRI/2024/01/061744尚未招募不适用

Real life evidence of Tab Ribociclib for Safety and Efficacy in a tertiary care centre (RERISE study).

Not applicable2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年1月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
2
主要终点
To study efficacy including Progression Free Survival and Overall Survival

研究概览

简要总结

In this retrospective observational study, data will be collected from patients who have Hormone positive, HER2 negative metastatic breast cancer and who have received Ribociclib along with endocrine treatment from Jun 2018 till Dec 2022.

Patients with altleast one available medical record on EMR will be included in the analysis. Progression free survival and overall survival will be studied.

Response will be assessed post evaluation of age, menopausal status, baseline tumor characteristics, ECOG, metastatic sites, comorbidities, previous anticancer treatment like surgery, radiation, chemotherapy lines received, ET lines, other ongoing treatments for comorbidities, visceral, non visceral disease .

 Data will be collected through EMR from all available records and reports such as blood investigations, radiological reports, physician notes and histopathological reports to assess the primary objective of the trial. Progression free survival will be calculated from the day of starting of Ribociclib to date of first disease progression either clinical or radiological. Overall survival and best response will be assessed. Toxicity will be graded as per CTCAE V 4.03. Adverse events and tolerability will be assessed along with time to recover from the toxicity. Dose reductions and interruptions will be studied.

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

  • 1 Patients with histopathologically confirmed ER or PR positive and HER2 negative locally advanced or metastatic breast cancer 2 Patients who have been started on Ribocliclib with atleast one record of treatment with Ribociclib from the year Jun 2018 till December 2022 will be included in study.
  • Data will be collected from the EMR.

排除标准

  • Patient with HER2 positive metastatic cancer.
  • Patients with no available data on EMR.

结局指标

主要结局

To study efficacy including Progression Free Survival and Overall Survival

时间窗: 12 months

次要结局

  • To study safety and toxicity.(12 months)

研究者

申办方类型
Other [Not applicable, no funding required.]
责任方
Principal Investigator
主要研究者

Dr Sudeep Gupta

Tata Memorial Center

研究点 (2)

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