EUCTR2015-004189-27-IT进行中（未招募）1 期
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II STUDY OF THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE IN COMBINATION WITH ATEZOLIZUMAB OR ATEZOLIZUMAB-PLACEBO IN PATIENTS WITH HER2-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE RECEIVED PRIOR TRASTUZUMAB AND TAXANE BASED THERAPY. - A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizuma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age >/=18 years.
- •- Archival tumor samples must be obtained from primary and/or metastatic sites
- •- Able to submit tumor tissue that is evaluable for programmed death- ligand 1 (PD-L1) expression
- •- Human epidermal growth factor-2 positive breast cancer (BC) as defined by an immunohistochemistry score of 3 or gene amplified by in-situ hybridization as defined by a ratio of >=2.0 for the number of HER2 gene copies to the number of chromosome 17 copies, prospectively tested by a Sponsor- designated central laboratory prior to enrollment. Both IHC and ISH assays will be performed; however, only one positive result is required for eligibility
- •- Histologically or cytologically confirmed invasive BC incurable, unresectable, locally advanced BC previously treated with multimodality therapy or metastatic breast cancer
- •- Prior treatment for BC in the adjuvant, unresectable locally advanced or metastatic settings which must include both, a taxane and trastuzumab (alone or in combination with another agent)
- •- Progression must have occurred during or after most recent treatment for locally advanced BC/MBC or within 6 months after completing adjuvant therapy
- •- Participants must have measurable disease that is evaluable as per RECIST v1.1
- •- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •- Adequate hematologic and end-organ function as evidenced by the following local laboratory results obtained within 2 weeks prior to the first study treatment (Cycle 1, Day 1):
- •Absolute neutrophil count >=1500 cells/microliter (µL) (without granulocyte-colony stimulating factor support) within 2 weeks prior to Cycle 1, Day 1
- •Platelet count >=100,000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
- •Hemoglobin >=9.0 gram/deciliter (g/dL)
- •Albumin > 2.5 g/dL
- •Aspartate aminotransferase, alanine transaminase, and alkaline phosphatase <= 2.5 × the upper limit of normal (ULN)
- •Total bilirubin <=1.5 × the ULN
- •International normalized ratio and activated partial thromboplastin time <=1.5 × the ULN
- •Calculated creatinine clearance >= 30 millilitre/min
- •- Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and for women less than 12 months after the onset of menopause
- •- For women of childbearing potential, agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of of trastuzumab emtansine or 5 months after the last dose of atezolizumab/placebo, whichever is later.Women must refran from donating eggs during this same period
- •- For men, agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm that together result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose trastuzumab emtansine.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Prior treatment with trastuzumab emtansine, cluster of differentiation 137 agonists, anti-programmed death 1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
- •- Receipt of any anti-cancer drug/biologic or investigational treatment within 21 days prior to Cycle 1 Day 1, except hormone therapy, which can be given up to 7 days prior to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other eligibility criteria
- •- Radiation therapy within 2 weeks prior to Cycle 1, Day 1
- •- History of exposure to the cumulative doses of anthracyclines
- •- History of other malignancy within the previous 5 years
- •- Cardiopulmonary dysfunction
- •- Patients with severe infection within 4 weeks prior to randomization,including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
- •- Current severe, uncontrolled systemic disease
- •- Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
- •- Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, sclerosis cholangitis or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
- •- Need for current chronic corticosteroid therapy
- •- 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 randomization
- •- Participants with known central nervous system disease
- •- Leptomeningeal disease
- •- Symptomatic pleural effusion, pericardial effusion, or ascites
- •- Uncontrolled hypercalcemia (>1.5 millimol/litre ionized calcium or calcium > 12 milligram/dL or corrected serum calcium greater than the ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- •- Current Grade >= 3 peripheral neuropathy
- •- History of autoimmune disease and idiopathic pulmonary fibrosis
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Active tuberculosis
- •- Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study
- •- Treatment with systemic immunostimulatory agents
- •- Treatment with systemic corticosteroids or other systemic immunosuppressive medications.
- •- Breastfeeding, or intending to become pregnant during the study.
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