EUCTR2020-003681-40-DE进行中（未招募）1 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY.
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
- 1,700
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
- •- Histologically confirmed invasive breast carcinoma
- •- Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph node(s) at surgery after completion of neoadjuvant therapy
- •- Diagnosis of HER2-positive breast cancer with assessment of hormone receptor and programmed death?ligand 1 status, as documented through central testing of a representative tumor tissue specimen
- •- Completion of preoperative systemic chemotherapy and HER2-directed treatment
- •- Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes
- •- An interval of no more than 12 weeks between the date of primary surgery and the date of randomization
- •- Eastern Cooperative Oncology Group Performance Status 0 or 1
- •- Screening left ventricular ejection fraction >= 50% on echocardiogram or multiple-gated acquisition scan after completion of neoadjuvant therapy and no decrease in left ventricular ejection fraction (LVEF) by more than 15% absolute points from the pre-chemotherapy LVEF. Alternatively, if the pre-chemotherapy LVEF was not assessed, the screening LVEF must be >= 55% after completion of neoadjuvant therapy
- •- Life expectancy >= 6 months
- •- Adequate hematologic and end organ function
- •- For women of childbearing potential: agreement to remain abstinent or to use non-hormonal contraception, and agreement to refrain from donating eggs during the treatment period and for 7 months after the final dose of trastuzumab emtansine or trastuzumab
- •- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 7 months after the final dose of trastuzumab emtansine or trastuzumab
- •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 1530
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •- Stage IV (metastatic) breast cancer;
- •- Inadequate excision;
- •- An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy;
- •- Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons;
- •- History of other malignancy within 5 years prior to screening;
- •- History of exposure to the following cumulative doses of anthracyclines:
- •o Doxorubicin > 240 mg/m2;
- •o Epirubicin or liposomal doxorubicin-hydrochloride (Myocet) > 480 mg/m2;
- •o For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2;
- •- Prior treatment with trastuzumab emtansine or atezolizumab;
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies;
- •- Current Grade >= 2 peripheral neuropathy;
- •- Dyspnea at rest;
- •- Cardiopulmonary dysfunction;
- •- Active or history of autoimmune disease or immune deficiency;
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis:
- •o History of radiation pneumonitis in the radiation field is permitted;
- •- Active tuberculosis;
- •- Current severe, uncontrolled systemic disease;
- •- Any known active liver disease;
- •- Major surgical procedure, other than for breast cancer, within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the study;
- •- Severe infection within 4 weeks prior to randomization;
- •- Treatment with therapeutic antibiotics within 2 weeks (IV antibiotics) or 5 days (oral antibiotics) prior to randomization;
- •- Prior allogeneic stem cell or solid organ transplantation;
- •- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug and may affect the interpretation of the results, or may render the patient at high risk from treatment complications;
- •- Treatment with a live, attenuated vaccine within 4 weeks prior to randomization, or anticipation of need for such a vaccine during atezolizumab/placebo treatment or within 5 months after the final dose of atezolizumab/placebo;
- •- Treatment with investigational therapy within 28 days prior to randomization;
- •- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to randomization;
- •- Treatment with systemic immunosuppressive medication within 2 weeks prior to randomization, or anticipation of need for systemic immunosuppressive medication during study treatment;
- •- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins;
- •- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation;
- •- History of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product;
- •- Pregnant or breastfeeding, or intending to become pregnant during study treatment within 7 months after the final dose of trastuzumab emtansine or trastuzumab.
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