RPCEC00000280已完成3 期
A PHASE III, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF ATEZOLIZUMAB PLUS CHEMOTHERAPY FOR PATIENTS WITH EARLY RELAPSING RECURRENT (INOPERABLE LOCALLY ADVANCED OR METASTATIC) TRIPLE-NEGATIVE BREAST CANCER - IMPassion 132
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
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
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years old 至 one（—）
- 性别
- All
入选标准
- •1. Histologically confirmed triple negative breast cancer(TNBC) that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
- •2. Documented disease progression occurring within 12 months from the last treatment with curative intent
- •3. Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. 4. Prior radiation therapy for recurrent disease is permitted
- •4. Measurable or non-measurable disease, as defined by RECIST 1.1
- •5. Availability of a representative formalin-fixed paraffin-embedded (FFPE) tumour block (preferred) or at least 25 unstained slides with an associated pathology report, if available
- •6. Eastern Cooperative Oncology Group performance status 0-1
- •7. Life expectancy = 12 weeks
- •8. Adequate haematologic and end-organ function
- •9. Negative human immunodeficiency virus (HIV) test ---Negative hepatitis B surface antigen (HBsAg) test at screening
- •10. Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive HBcAb test
- •11. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening.
- •12. Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of =1% per year during the treatment period and for at least 5 months after the last dose of study treatment
- •13. Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm
排除标准
- •1. Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation
- •2. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- •3. Symptomatic or rapid visceral progression
- •4. No prior treatment with an anthracycline and taxane
- •5. History of leptomeningeal disease
- •6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) (patients with indwelling catheters such as PleurX® are allowed)
- •7. Uncontrolled tumour-related pain
- •8. Uncontrolled or symptomatic hypercalcemia
- •9. Malignancies other than TNBC within 5 years prior to randomisation)
- •10. Significant cardiovascular disease, within 3 months prior to randomisation, unstable arrhythmias, or unstable angina
- •11. Presence of an abnormal ECG
- •12. Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
- •13. Current treatment with anti-viral therapy for HBV.
- •14. Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis
- •15. Treatment with investigational therapy within 28 days prior to randomisation
- •16. Pregnant or lactating, or intending to become pregnant during or within 5 months after the last dose of study treatment
- •Related to Atezolizumab:
- •17. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins
- •18. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation
- •19. History of autoimmune disease
- •20. Prior allogeneic stem cell or solid organ transplantation
- •21. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computerised tomography (CT) scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •22. Active tuberculosis
- •23. Receipt of a live, attenuated vaccine within 4 weeks prior to randomisation or anticipation that a live, attenuated vaccine will be required during atezolizumab/placebo treatment or within 5 months after the last dose of atezolizumab/placebo
- •24. Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents
- •25. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to randomisation
- •26. Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomisation, or anticipated requirement for systemic immunosuppressive medications during the trial
- •Related to Capecitabine:
- •27. Inability to swallow pills
- •28. Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis
研究者
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