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 sites40 target enrollmentMay 24, 2024

Overview

No summary available.

Registry

who.int

Start Date

May 24, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Istituto Europeo Di Oncologia S.r.l.

•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