NCT04769050Unknown不适用
A Phase II, Single-center, Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The correlation between the change of HER2-PET at baseline and after 2 courses of treatment and ORR.
研究概览
简要总结
Dynamic observationaL study with PET of 68Ga-HER2-affibody in anti-HER2 treatment
详细描述
Participants participated in the screening period visit, and received HER2-PET and 18 F-FDG PET/CT examinations before receiving tumor treatment, after receiving 2 cycles of chemotherapy, and after disease progression. Patients of first-line received docetaxel combined with trastuzumab±pertuzumab regimen, and patients of second-line received T-DM1 monotherapy or capecitabine combined with pyrrotinib regimen.
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
- •Subjects voluntarily joined the study, signed informed consent, and had good compliance.
- •Female patients aged over 18 years (including cutoff value).
- •an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Patients with HER2 positive recurrent or metastatic breast cancer confirmed by histopathology.
- •At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.
- •Previously received no more than 1 prior lines of systemic chemotherapy for metastatic breast cancer
- •Life expectancy ≥ 12 weeks.
- •Adequate function of major organs meets the following requirements (no blood components and cell growth factors have been used within 14 days before randomization):
- •Neutrophils ≥ 1.5×10^9/L
- •Platelets ≥ 75×10^9/L
- •Hemoglobin ≥ 80g/L
- •Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
- •ALT and AST ≤ 3 × ULN
- •BUN and Cr ≤ 1.5 × ULN
- •Left ventricular ejection fraction (LVEF) ≥ 50%
- •QTcF(Fridericia correction) ≤ 470 ms
排除标准
- •The subject has untreated central nervous system (CNS) metastases.
- •Patients who have undergone systemic, radical brain or meningeal metastasis (radiotherapy or surgery), but have been confirmed to have been stable for at least 4 weeks, and who have stopped systemic hormonal therapy for more than 2 weeks without clinical symptoms can be included.
- •Received systemic therapy such as chemotherapy, molecular targeted therapyment;received endocrine therapy within 2 weeks before enrollment.
- •Patients with other malignant tumors within 3 years or at the sametime(except for cured skin basal cell carcinoma and cervical carcinomain situ).
- •Have undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or are expected to undergo major surgery.
- •Pregnant women, lactating female, or women of childbearing age who are unwilling to take effective contraceptive measures.
- •Have a history of allergies to the drug components of this regimen.
- •Patients with active HBV and HCV infection; stable hepatitis B after drug treatment (HBV virus copy number is higher than the upper limit of reference value) and cured hepatitis C patients (HCV virus copy number exceeds the lower limit of detection method).
- •History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation.
- •History of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥ grade 2 found in screening.
- •Female patients who are pregnancy, lactation or women who are ofchildbearing potential tested positive in baseline pregnancy test.
- •Childbearing female who refuse to accept any contraception practice.
- •Determined by the physician, any serious coexisting disease might be harmful to the patient's safety or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,active infection etc.).
- •History of neurological or psychiatric disorders, including epilepsy or dementia.
- •Severe infections within 4 weeks prior to first dose (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs according to clinical protocols), or unexplained fever (T > 38.3 °C ) during screening or prior to first administration
研究组 & 干预措施
First-line patients
First-line treatment of HER2-positive metastatic breast cancer patients
干预措施: Docetaxel combined with Trastuzumab±Pertuzumab (Drug)
Second-line patients
Second-line treatment of HER2-positive metastatic breast cancer patients
干预措施: T-DM1 or Capecitabine combined with Pyrotinib regimen. (Drug)
结局指标
主要结局
The correlation between the change of HER2-PET at baseline and after 2 courses of treatment and ORR.
时间窗: 2 year
The correlation between the percent change in standardized uptake value (SUV) on 68Ga-Affibody HER-2 Imaging PET at baseline and after 2 courses of treatment and objective response rate(ORR).
次要结局
- The correlation between the change of HER2-PET at baseline and after 2 courses of treatment and PFS(2 year)
- The correlation between baseline HER2 expression and ORR, PFS(2 year)
- The correlation between heterogeneity of baseline HER2 expression and ORR, PFS(2 year)
- To explore the condition of HER2-PET when PD.(2 year)
研究者
Xichun Hu
Director of department of medical oncology
Fudan University
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCRRecurrent or Metastatic Breast CancerNCT03947736Chinese Academy of Medical Sciences200
尚未招募
不适用
Efficacy analysis of anti-HER2 treatment in HER2-enriched early breast cancer identified by PAM50KCT0006154Yonsei University Health System, Gangnam Severance Hospital59
Unknown
早期 1 期
Clinical Study of 68Ga Labeled HER2 Affibody AnaloguesHER2-positive Breast Cancer and Gastric CancerNCT05411432Xijing Hospital56
招募中
不适用
PET Imaging of 68Ga-Her2-affibody in Tumors with High Her2 ExpressionNeoplasmsNCT06289517Peking University First Hospital30
已完成
1 期
PET Study of Breast Cancer Patients Using [68Ga]ABY-025Breast CancerNCT01858116Biomedical Radiation Sciences16