NCT04683770Unknown不适用
An Observational Study：Prognostic Value of Biomarkers in HR + / HER2 - Advanced Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlation between biomarkers and efficacy of tumor therapy
研究概览
简要总结
Our study is aimed to explore a prospective observational clinical study on the efficacy prediction and survival prediction of HR + / HER2 - biomarkers detection in patients with advanced breast cancer. This study is a prospective, observational clinical study. We analyzed the incidence of biomarker mutations in HR + / HER2 - advanced breast cancer (stage IV), and the correlation between biomarkers and therapeutic efficacy, survival, and prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients (aged 18-80 years, including 18 and 80 years) with advanced breast cancer confirmed by pathology or imaging are not suitable for surgical resection or radiotherapy for the purpose of cure;
- •Pathological examination confirmed that ER and/or PR were positive and HER-2 was negative (ER expression: immunohistochemical staining > 1% of tumor cells; PR expression: immunohistochemical staining of tumor cells > 1%; HER-2 negative: immunohistochemical staining of 0,1 +, or fish / CISH negative)
- •No more than four systematic treatments have been used for advanced diseases
- •It is expected that the patients can be followed up at least once after the treatment plan is formulated.
- •The WHO physical status was 0-2 points, and the expected survival time was not less than 3 months;
- •No more than four systematic treatment regimens have been received in the past for advanced diseases
- •There was at least one measurable lesion (short diameter of lymph node ≥ 15mm) in imaging examination within 2 weeks before enrollment, and a conventional CT scan was performed. The diameter of spiral CT scan was more than or equal to 20 mm or more than 10 mm.
- •Prior treatment-related toxicity should be reduced to NCI CTCAE (version 4.03) ≤ 1 degree (except for hair loss or other toxicity judged by the researcher as having no risk to the safety of patients)
- •Within one week before admission, blood routine examination was basically normal: A. white blood cell count (WBC) ≥ 3.0 × 10 ^ 9 / L; B. neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L; C. platelet count (PLT) ≥ 100 × 10 ^ 9 / L;
- •Within one week before admission, liver, and kidney function tests were basically normal (based on the normal values of laboratories in each research center): A. total bilirubin (TBIL) ≤ 1.5 × ULN; B. alanine aminotransferase and aspartate aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastases ≤ 5xuln); C. serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml/min；
排除标准
- •The diagnosis of any other malignant tumor within 3 years before enrollment, except for basal cell or squamous cell skin cancer or cervical carcinoma in situ after adequate treatment;
- •Poor compliance or the situation that the researchers think is not suitable to be included in the study;
- •Pregnant or lactating patients;
- •Patients who had received transplantation before;
- •Patients who had previously received stem cell therapy;
- •Patients who have received any immunotherapy that may introduce exogenous DNA and other patients who may introduce exogenous DNA within 4 weeks;
- •Have received more than four systematic treatments for advanced diseases;
- •May interfere with the concomitant diseases or conditions involved in the study, or have any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection);
结局指标
主要结局
Correlation between biomarkers and efficacy of tumor therapy
时间窗: 1 year
explore the correlation between biomarkers and the ORR. The biomarkers will be test by nest-generation sequence, which include 520 genes and tumor mutation burden, like ERBB2/TP53/PIK3CA/ERBB4/CCND1 and so on.
次要结局
- Clinical benefit rate, CBR(1 year)
- Partial remission, PR(1 year)
- overall survival，OS(2 year)
- Disease stable, SD(1 year)
- Disease progression, PD(1 year)
- Complete remission, CR(1 year)
- Quality of life scale score，QoL(1 year)
- Objective response rate , ORR(1 year)
研究者
Jianli Zhao
Attending Doctor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
研究点 (1)
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