jRCTs021210010招募中不适用
A phase II study of combination of radiotherapy and Atezolizumab/nab-paclitaxel for inoperable or recurrent PD-L1 positive triple negative breast cancer (IMRad-Br)
未提供0 个研究点目标入组 20 人开始时间: 2022年4月14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
- 20
- 主要终点
- Incidence rate of pre-specified adverse events of interest (PAEIs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Written informed consent has been obtained from the patient himself / herself.
- •(2) Age 20 years / over
- •(3) Histologically confirmed inoperable or recurrent triple-negative breast cancer (without HER2, ER, PR expression, with PD-L1 expression).
- •HER2-negative is evaluated in the each institution according to one of the following definitions.
- •No amplification in in situ hybridization (ISH), or IHC 0 or IHC 1+
- •ER and PR negative are defined as less than 10% of hormone receptor-expressing cells in IHC analysis.
- •PD-L1 positive means that the PD-L1 score in the tumor tissue is IC 1 or higher in the IHC analysis using the SP142 antibody.
- •(4) Within 2 regimens of chemotherapy or systemic targeted therapy for the breast cancer
- •(5) ECOG Performance Status 0-2
- •(6) Patients who can be expected to survive for 12 weeks or more
- •(7) Patients with lesions for which local radiotherapy is an indication
- •(8) The latest L/D within 14 days before registration satisfies all of the following.
- •White blood cell count <= 12,000 / muL
- •Neutrophil count => 1500 / muL
- •Lymphocyte count => 500 / muL
- •Platelet count => 100,000 / muL
- •Hemoglobin => 9.0 g / dL
- •AST, ALT, <= 2.5 x upper limit of normal value (ULN)
- •(patients with liver metastasis: AST and ALT <= 5 x ULN are allowed)
- •Alkaline phosphatase <= 2.5 x upper limit of normal value (ULN)
- •(patients with liver or bone metastasis: Alkaline phosphatase <= 5 x ULN is allowed)
- •Serum bilirubin <= 1.25 x ULN
- •(in Gilbert's syndrome, serum bilirubin level <= 3 x ULN is allowed)
- •INR and aPTT <= 1.5 x ULN
- •Estimated creatinine clearance => 30 mL / min
排除标准
- •V20 (ratio of lung volume irradiated above 20 Gy to total lung volume) is expected to exceed 20%
- •Heterozygous / synchronous double cancer (excluding cervical carcinoma in situ, well-treated basal cell carcinoma of the skin, intramucosal cancer of the digestive tract, and malignant tumors treated more than 5 years ago without recurrence)
- •Patients with a history of hypersensitivity to the ingredients of atezolizumab preparations, patients with a history of hypersensitivity to Nab-paclitaxel or additives. And, have a history of high hypersensitivity reaction to other antibody preparations (if it develops before 2 years and there is no recurrence, it can be registered).
- •Receive continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs. However, temporary use or use of low doses of prednisolone or prednisolone equivalent less than 15 mg / day can be registered.
- •Patients with or with a history of recurrent autoimmune disease. However, it does not include the patients with hypothyroidism that can be controlled by hormone replacement therapy and skin diseases that do not require systemic management (white spots, psoriasis, alopecia, etc.).
- •Have one or more of interstitial pneumonia, pulmonary fibrosis, severe emphysema diagnosed by diagnostic imaging (preferably diagnosed by CT) or clinical findings. A history of radiation pneumonitis (fibrosis) in the irradiation field is acceptable.
- •Have the following serious illnesses or conditions
- •Significant nutritional disorders
- •Transient ischemic attack, cerebrovascular attack, thrombosis, or thrombotic embolism within 180 days before full registration
- •Congestive heart failure (NYHA Class III or IV)
- •Unstable angina or myocardial infarction within 6 months
- •Severe arrhythmia requiring medication and AV block exceeding the second degree
- •Uncontrollable high blood pressure
- •Cirrhosis (Child Class B or above)
- •Mental disorders that may interfere with compliance with this study implementation plan
- •Diabetes under treatment or uncontrolled due to continuous use of insulin
- •Uncontrollable pericardial fluid, ascites or pleural effusion
- •Anticoagulant therapy (excluding antiplatelet therapy such as low-dose aspirin) is required
- •Uncontrolled, valvular disease, dilated cardiomyopathy, hypertrophic cardiomyopathy
- •Pregnant or lactating women
- •Women of childbearing potential who are not willing to contracept, and partner men who are fertile and unwilling to contracept for 7 months after the end of study.
- •Have the following pretreatment history within 56 days from the registration date:
- •Radiopharmaceuticals (excluding radiopharmaceuticals for testing and diagnosis)
- •Within 28 days from the registration date:
- •Systemic corticosteroid
- •(Excluding temporary use, prednisolone or prednisolone equivalent less than 15 mg / day)
- •Immunosuppressant
- •Antineoplastic agents (chemotherapy, molecular targeted therapy, immunotherapy, etc.)
- •Adhesion of the pleura or pericardium
- •Surgical therapy with general anesthesia
- •Administration of unapproved drugs
- •Within 14 days from the registration date:
- •Surgical therapy with local or surface anesthesia(CV port placement, dental treatment, etc. which do not affect the primary endpoint, are not included.)
- •Participating in other clinical trials or clinical studies (excluding trials without intervention)
- •Positive for HIV antigen / antibody test or HTLV-1 antibody test
- •In the past, anti-PD-L2 antibody, anti-CD137 antibody,Anti-CTLA-4 antibody or other antibody therapy or drug therapy aimed at controlling T cells Has a history of pretreatment.If the subjects have using anti-PD-1 antibodies or anti-PD-L1 antibodies previously, they can register, but in that case, 6 weeks have need passed since the last administration before the start of research treatment. In that case, the attending physician must have determined that there will be no problem with the safety or evaluation of participation.
- •Cases in which the investigator determined that participation in this study was inappropriate
- •Have a fever of 38 degrees or higher at the time of registration
- •HBsAg / antibody positive or HCV antibody positive
结局指标
主要结局
Incidence rate of pre-specified adverse events of interest (PAEIs)
时间窗: 3 months after completion of irradiation
The following adverse events* occurred within 3 months after completion of irradiation - Grade 3-4 non-hematologic, non-dermal, non-pulmonary related toxicity - Fever over 38.5 degree with ANC<1,000/muL - Neutrophil count reduction of <500/muL lasting longer than 5 days - Significant bleeding with platelet count <40,000/muL or platelet count <20,000/muL - Grade 4 skin disorder - Development of radiation pneumonitis outside the radiation range, regardless of grade - All Grade 2 pulmonary events that do not recover to Grade 1 or lower within 12 weeks - Grade 2 pulmonary event, once recovered, but with a recurrence of a Grade 2 pulmonary event (relapse) - All pulmonary events of Grade 3-4 - Encephalitis or meningitis of any grade
次要结局
未报告次要终点
研究者
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