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.

F. Hoffmann-La Roche Ltd0 个研究点目标入组 202 人开始时间: 2016年7月8日最近更新: 2020年7月13日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: F. Hoffmann-La Roche Ltd
入组人数: 202

研究概览入排标准研究者记录与标识符相似试验

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 trastuzumab emtansine or 5 months after the last dose of atezolizumab/placebo, whichever is later. Women must refrain 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.

研究者

发起方

F. Hoffmann-La Roche Ltd

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