EUCTR2019-001503-20-FR进行中（未招募）1 期
PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FIRST LINE ATEZOLIZUMAB IN COMBINATION WITH PACLITAXEL AND BEVACIZUMAB (AVASTIN®) IN PATIENTS WITH ADVANCED OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER - Phase II First Line Atezolizumab, PacliTaxel, and Bevacizumab (Avastin®) in mTNBC
Medica Scientia Innovation Research (MedSIR)0 个研究点目标入组 100 人开始时间: 2020年6月19日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent form (ICF) prior to participation in any study-related activities
- •2. Male or female patients = 18 years at the time of signing ICF
- •3. Ability to comply with the study protocol, in the investigator's judgment
- •4. Histologically confirmed TNBC –regardless of PD-L1 status– per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria based on local testing on the most recent analyzed biopsy. Triple-negative is defined as <1% expression for estrogen receptor (ER) and progesterone receptor (PgR) as determined by immunohistochemistry (IHC),and negative for HER2 (0–1+ by immunohistochemistry [IHC] or 2+ and negative by in situ hybridization [ISH] test)
- •5. Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent
- •6. No prior chemotherapy and/or targeted therapy and/or immunotherapy and/or antiangiogenic agent for MBC. Patients who have received (neo)adjuvant taxane-based chemotherapy and/or immunotherapy and/or an antiangiogenic agent are required to have a disease-free interval (DFI) of at least 12 months after completion of each of these treatments. For (neo)adjuvant non-taxane-based chemotherapy, a DFI of at least 6 months is required
- •7. Resolution of all acute toxic effects of prior anti-cancer therapy to grade = 1 as determined by the NCI-CTCAE v.5.0 (except for alopecia, grade = 2 peripheral neuropathy, or other toxicities not considered a safety risk for the patient at investigator's discretion)
- •8. Evidence of measurable disease or non-measurable disease as per RECIST v.1.1. Patients with only bone lesions are also eligible
- •9. Willingness and ability to provide the most recent tumor biopsy since last progression from either metastatic or primary tissues at the time of the inclusion to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor’s qualified designee. An additional tumor biopsy from either metastatic or primary (only if metastatic biopsies cannot be obtained for inaccessible lesion or subject safety concern) tissues would be collected at disease progression or study termination whenever it is feasible
- •10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •11. Life expectancy of =12 weeks
- •12. Adequate hematologic and organ function within 14 days before the first study treatment on Cycle 1 Day 1 (C1D1), defined by the following parameters:
- •a. Hematological:i. White blood cell (WBC) count > 3.0 x 109/L; ii. Absolute neutrophil count (ANC) > 1.5 X 109/L; iii. Lymphocyte count 0.5 x 109/L (500L); iv. Platelet count 75.0 x 109/L; v. Hemoglobin > 9.0 g/dL
- •b. Hepatic: Bilirubin = 1.5 times the upper limit of normal (× ULN) (= 3 x ULN in the case of Gilbert’s disease); aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 × ULN (in the case of liver metastases = 5 × ULN); alkaline phosphatase (ALP) = 2.5 × ULN (= 5 × ULN in the case of liver and/or bone metastases).
- •c. Serum albumin = 2.5 g/dL
- •d. Renal: Serum creatinine < 1.5 × ULN or creatinine clearance = 50 mL/min based on Cockcroft-Gault glomerular filtration rate estimation. No proteinuria by urinalysis. In cases of proteinuria > ULN by urinalysis, proteinuria should be less than 500 mg by 24-hour urine collection.
- •e. Coagulation:
- •- For patients not receiving therapeutic anticoagulation: Partial Thromboplastin Time
排除标准
- •1. Known active uncontrolled or symptomatic central nervous system (CNS) metastases as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases are eligible if they meet the following criteria:
- •Evidence of measurable disease or non-measurable disease as per RECIST v.1.1.
- •The patient has no history of intracranial hemorrhage.
- •The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
- •The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.
- •2. History of leptomeningeal disease.
- •3. Uncontrolled tumor-related pain.
- •4. Active or history of autoimmune disease or immune deficiency
- •5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •Note: Patients with indwelling catheters (e.g., PleurX®) are allowed.
- •6. Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L; calcium > 12 mg/dL).
- •7. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
- •8. Active tuberculosis.
- •9. Significant cardiovascular disease 6 months prior to initiation of study treatment. These include New York Heart Association Class II or greater cardiac disease, myocardial infarction, unstable arrhythmia, or unstable angina, symptomatic pericarditis, ventricular arrhythmias –except for benign premature ventricular contractions–, arrhythmias or conduction abnormalities requiring a pacemaker or not controlled with medication, and prior peripheral vascular disease including any cerebrovascular accident including transient ischemic attack, any pulmonary embolism, any prior deep vein thrombosis, and/or any grade = 2 peripheral vascular disease.
- •10. Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO).
- •11. Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 100 mmHg).
- •12. Major surgical procedure (defined as requiring general anesthesia) or significant traumatic injury within 28 days of start of study drug, or patients who have not recovered from the side effects of any major surgery.
- •13. Concurrent malignancy(ies) or malignancy(ies) within 5 years of study enrollment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.
- •14. Treatment with therapeutic oral or IV antibiotics or severe infection 2 weeks prior to initiation of study treatment.
- •Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
- •15. Prior allogeneic stem cell or solid organ transplantation
- •16. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizuma
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