跳至主要内容
临床试验/NCT06503380
NCT06503380招募中不适用

Real-world Study on the Management of Hematological Toxicities Associated With Targeted Therapies for Breast Cancer

Fudan University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Incidence of cancer treatment induced neutropenia (CIN)

研究概览

简要总结

This multicenter, real-world, observational study will retrospectively and prospectively collect real-world data related to the investigational drugs. We plan to observe 1000 patients and collect data on treatment cycles N and N+1 of the targeted therapies. Retrospective data collection is based on existing patient diagnosis and treatment records, collecting information on patients who have completed two treatment cycles before January 1, 2024. Prospective data collection is based on routine clinical treatment during the study period, collected until the end of the next cycle of treatment or early termination of the study. To observe the disease characteristics and management mode of hematological toxicity related to targeted therapies of breast cancer, and explore the possible related factors of hematological toxicity, such as age, disease subtype, cancer stage, targeted therapy regimens, etc. This study will respect the medication choices of researchers in the study, without specifying which medication to choose for treatment, dosage, mode of administration (including single drug, combination therapy, or sequential therapy), and duration of administration.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • · The patients signed the informed consent and voluntarily participated in the study.
  • A definite diagnosis of any type of breast cancer.
  • Receiving or has completed targeted therapies.
  • Investigator judged that the patient need to receive or had received treatment or prevention for CTIT, CIN or CRA induced by targeted therapies.

排除标准

  • · Pregnant or lactating women.
  • Failure to understand the study or to obtain informed consent.
  • The investigator determined other situations that are not suitable for inclusion.

结局指标

主要结局

Incidence of cancer treatment induced neutropenia (CIN)

时间窗: Approximately 2 years

The occurrence, prevention, treatment of neutropenia associated with targeted therapies. The influence of different baseline characteristics of patients on treatment outcomes and efficacy and safety of drugs.

次要结局

  • Incidence of cancer therapy induced thrombocytopenia (CTIT)(Approximately 2 years)
  • Incidence of cancer related anemia (CRA)(Approximately 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhimin Shao

Director of General Surgery of Fudan Shanghai Cancer Center

Fudan University

研究点 (1)

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