A Real-world Observational Study on the Efficacy and Safety of Anti HER2 Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs.
详细描述
About 30% of breast cancer is human epidermal growth factor receptor-2 (HER2) amplification or overexpression (i.e. HER2 positive). HER2 positive breast cancer is one of the indicators of poor prognosis because of its high risk of invasion and metastasis. Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs including antibody drugs such as trastuzumab and pertuzumab, small-molecule tyrosine kinase inhibitors (TKIs) such as lapatinib, neratinib, and pyrotinib, and antibody-drug conjugates such as trastuzumab deruxtecan (DS-8201) and trastuzumab emtansine (T-DM1).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, voluntary consent and signed written informed consent.
- •Diagnosis of locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer.
- •At least one measurable disease lesion before treatment.
- •Anticipated survival time is longer than three months.
- •Pathological and IHC reports for ER, PR, HER2 and Ki67 are available.
- •For women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment
- •There are traceable medical records during treatment.
排除标准
- •Pregnant or lactating women. Active infection requiring systemic treatment。
- •HIV positive
- •Suffering from or suspected of suffering from central nervous system diseases.
- •Serious heart disease.
- •Pulmonary lymphatic involvement leads to pulmonary dysfunction and requires active treatment, including the use of oxygen
- •The investigator considered that the patient was not suitable for in this study, with any other situation.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From date of randomization until the date at the end of the second treatment cycle (42 days)
The total rate of CR+PR after the completion of two cycles of treatment.
Progression-Free Survival (PFS)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The survival time from the date of recruitment to the date of the first documented progression or date of death.
Adverse Events
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
All adverse events \[including adverse events (AE / SAE) and ADR (adverse drug reactions)\] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.
次要结局
未报告次要终点