Phase II study to test whether a combination of three drugs—atezolizumab, vinorelbine, and weekly cyclophosphamide—can activate T-cells in patients with a specific type of advanced breast cancer called triple negative breast cancer.

Phase 1

Conditions: Inoperable locally advanced or metastatic TNBC patients, previously treated with anti-PD-L1/PD1- regimens
MedDRA version: 23.0Level: LLTClassification code: 10084066Term: Triple negative breast cancer metastatic Class: 10029104
MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-514031-20-00

Lead Sponsor: Istituto Europeo Di Oncologia S.r.l.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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