NCT06479460招募中不适用
Director, Department of Pathology, Jiangsu Provincial People's Hospital
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月8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
- 50
- 试验地点
- 1
- 主要终点
- Postoperative pathological pCR rate
研究概览
简要总结
- To explore the predictive value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population;
- To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population.
详细描述
This study plans to enroll 50 HER2 positive breast cancer patients in early stage (T2-3, N0-1, M0)/local late stage (T2-3, N2-3, M0 or T4a-c, Nany, M0), collect baseline tumor tissue samples of patients, as well as peripheral blood samples of multiple nodes at baseline, during new adjuvant therapy, after new adjuvant therapy (before surgery), and after surgery, detect the mutation of tumor tissue through 1021 panel, and conduct ctDNA detection of peripheral blood samples based on personalized panel design based on tumor tissue specific mutations, to explore the efficacy prediction and prognostic predictive value of ctDNA in HER2 positive new adjuvant therapy population.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with breast cancer diagnosed clinically and pathologically, aged 18-75 years;
- •ECOG performance score is 0-1;
- •Histologically confirmed as early or locally advanced invasive breast cancer: the diameter of the primary tumor is more than 2 cm, and HER2 is positive (confirmed by IHC or FISH).
- •The patient did not receive any treatment for breast cancer before enrollment;
- •Having lesions measurable according to RECIST 1.1 standards;
- •The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up; 7) Breast cancer patients who plan to use neoadjuvant therapy.
- •Exclusion criteria
- •Patients with known metastatic or stage IV breast cancer;
- •There are other untreated malignant tumors other than breast cancer;
- •Patients with one or more serious systemic diseases that, in the eyes of researchers, can impair their ability to complete research;
- •According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subjects or the collection of experimental data.
- •Unable to follow up with the study according to the determined clinical follow-up period;
- •Cannot accept or provide specified efficacy evaluation methods such as CT.
- •Unable to obtain sufficient tumor tissue samples or peripheral blood samples.
排除标准
- •Patients with known metastatic or stage IV breast cancer; 2) There are other incurable malignant tumors present; 3) One or more serious systemic diseases that, in the eyes of researchers, can impair the patient's ability to complete the study; 4) According to the researcher's judgment, there are other factors that may cause the subject to be forced to terminate the study midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subject or the collection of trial data.
- •Unable to follow the determined clinical follow-up period in conjunction with the study for follow-up; 6) Unable to accept or provide specified efficacy evaluation methods such as CT.
结局指标
主要结局
Postoperative pathological pCR rate
时间窗: 2024.3 -- 2026. 3
Postoperative pathological pCR rate of HER-2 positive breast cancer patients after completing neoadjuvant therapy and undergoing surgical resection
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBCBreast CancerNCT04803539Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University260
招募中
不适用
ctDNA Screening in Advanced HER2 Positive Gastric CancerHER2-positive Gastric CancerNCT04520295Ruijin Hospital100
招募中
2 期
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast CancerBreast NeoplasmsHER2-positive Breast CancerCirculating Tumor CellNCT04993014AC Camargo Cancer Center80
招募中
1 期
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for HER2 Positive Early Breast Cancer PatientsHER2-positive Early Breast CancerNCT04750122Peking University People's Hospital46
招募中
2 期
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBCTriple-negative Breast CancerNCT04501523Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University460