AZALEA: A Phase II study of atezolizumab, vinorelbine and weekly cyclophosphamide as T-cell activators in first line metastatic triple negative breast cancer patients pre-treated with anti-PD-L1/PD-1

Istituto Europeo Di Oncologia S.r.l.0 个研究点目标入组 40 人开始时间: 2024年5月24日最近更新: 2024年8月21日

试验速览

暂无简介。

•Patients with unresectable locally advanced or metastatic, histologically locally documented TNBC (negative for HER2 and ER and PgR)., Patient with at least one specimen positive (primary site and/or metastatic site) for PD-L1 status as determined by VENTANA PD-L1 SP142 IHC assay, performed locally., Prior treatment with anti-PD-L1/PD-1-containing regimens in the neoadjuvant/adjuvant setting., Life expectancy =12 weeks., Measurable disease, as defined by RECIST v1.1., Adequate haematologic and end-organ function

•Patients with de novo mTNBC OR those who have received 1 or more chemotherapy or targeted systemic therapy (including endocrine therapy) or immunotherapy regimens for advanced disease, 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 the first dose of study treatment (Cycle 1, Day 1)., Uncontrolled symptomatic pleural effusion, pericardial effusion, or ascites, Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease, Significant cardiovascular disease

发起方

Istituto Europeo Di Oncologia S.r.l.