EUCTR2020-000245-13-ES进行中（未招募）1 期
A Phase II with 2 parallel cohorts clinical trial targeting estrogen receptor negative or PAM50 non-luminal disease with Atezolizumab in combination with Trastuzumab and Vinorelbine in HER2-positive advanced/metastatic breast cancer – ATREZZO Study - ATREZZO
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- SOLTI
- 入组人数
- 110
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
- •1. Written signed ICF.
- •2. Male or female patients. Premenopausal or postmenopausal women.
- •3. Age 18 years or older
- •4. ECOG performance status 0 to 2
- •5. Histologically confirmed adenocarcinoma of the breast, metastatic or unresectable locally advanced.
- •a. Patients with standard curative options available will not be eligible.
- •b. Invasive HER2-positive breast cancer in the last biopsy performed
- •c. In patients with bilateral breast cancer, HER2+ positivity must be demonstrated in both sites or in the last metastatic biopsy.
- •d. Hormone receptor negative according to the local laboratory in the last biopsy performed, OR Hormone receptor positive breast cancer in the last biopsy performed according to the local laboratory, AND centrally confirmed non-luminal intrinsic subtype as per PAM50 analysis (i.e. HER2-E or Basal-like).
- •6. All patients must have received at least pertuzumab/trastuzumab and T-DM1 in one as follows situation:
- •a. For patients with newly diagnosed HER2+ advanced disease or advanced disease that recurred after 6 months of last dose of adjuvant therapy, must have received at least 2 previous lines of systemic treatment for metastatic disease with trastuzumab/pertuzumab and T-DM1
- •b. For patients who recur during or within 6 months after completing adjuvant therapy with trastuzumab +/- pertuzumab can be enrolled after one line of systemic treatment for metastatic disease with T-DM1.
- •c. For patients who recur during or within 6 months after completing adjuvant treatment with T-DM1 and neoadjuvant therapy with trastuzumab and pertuzumab can be enrolled directly in the moment of the diagnosis of metastatic disease.
- •d. Previous use of other anti-HER2 treatments, alone or in combination with chemotherapy, is permitted, including lapatinib, neratinib, trastuzumab, tucatinib, other anti-HER2 antibody drug conjugates or antiHER2 tyrosine-kinase inhibitors.
- •e. Previous use of any hormone agent or chemotherapy (except Vinorelbine or any other vinca alkaloids) is permitted.
- •a. Availability of formalin-fixed paraffin-embedded (FFPEThe tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for PD-L1 expression and PAM50 test (if HR positive) prior to enrolment. Patients whose tumor tissue is not evaluable for prospective central testing are not eligible.
- •7. Measurable disease according to RECIST 1.1 criteria
- •8. Adequate organ function,
- •9. Baseline LVEF =50% measured using echocardiogram or equilibrium isotopic ventriculography (MUGA).
- •10. Absence of psychological, family, sociological or geographical conditions that could potentially hinder compliance with the study protocol and follow-up schedule. These situations must be discussed with the patient before she is included in the study.
- •11. If female of childbearing potential, must have a negative result of serum pregnancy test performed within 7 days prior to first dose of study treatment.
- •12. Participants with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:
- •- Measurable disease outside the CNS is present.
- •- No evidence of interim CNS progression between the completion of CNS-directed therapy and the screening radiographic study.
- •- Metastases are limited solely to cerebellar and supratentorial lesions (i.e., no metastases to midbrain, pons, medulla, spinal cord, leptomeningeal metastases or carcinomatosis leptomeningeal)
- •- No stable requirement for corticosteroids or antic
排除标准
- •1. Treatment with any investigational anticancer drug within 14 days of the start of study treatment.
- •2. Patient has received Vinorelbine or any other vinca alkaloids previously.
- •3. History of other malignant tumors in the past 3 years, except for adequately treated in situ carcinoma of the cervix, non-melanoma carcinoma of the skin, uterine cancer in stage I or other malignant tumors with an expected curative outcome.
- •4. Patients who have received radiation therapy for metastases outside the brain carried out in the 21 days prior to inclusion in the study and/or patients who have received radiation to > 30% of the bone marrow.
- •5. Symptomatic hypercalcemia requiring treatment with bisphosphonates in the 14 days prior to inclusion in the study. Bisphosphonates or RANKL inhibitor, will be permitted for the prevention of bone events.
- •6. History of exposure to cumulative anthracycline doses greater than follows:
- •a. Adriamycin > 400 mg/m2
- •b. Epirubicin > 720 mg/m2
- •c. Mitoxantrone > 120 mg/m2
- •d. Idarubicin > 90 mg/m2
- •e. If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 400 mg/m2 of adriamycin.
- •7. Cardiopulmonary dysfunction
- •8. Any other severe, uncontrolled disease (pulmonary, cardiac, metabolic, or hematological disorder, wound healing disorders, ulcers, bone fractures, infectious processes).
- •9. Major surgery in the 28 days prior to enrolment or foreseeable during study treatment period.
- •10. Infection with HIV or active Hepatitis B and/or Hepatitis C.
- •11. History of trastuzumab intolerance, including grade 3-4 infusion reaction or hypersensitivity.
- •12. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the atezolizumab formulation
- •13. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barré syndrome, multiple sclerosis , vasculitis, or glomerulonephritis. (Note: Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study.)
- •14. Prior allogeneic stem cell or solid organ transplantation
- •15. 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 CT scan. (Note: History of radiation pneumonitis in the radiation field [fibrosis] is permitted.)
- •16. Active tuberculosis
- •17. Receipt of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study.
- •Note: Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 28 days prior to enrolment, during treatment or within 5 months following the last dose of atezolizumab
- •18. Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or immune checkpoint targeting agents
- •19. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of th
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