RecruitingPhase 2NCT06690840

Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients

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


Sponsor

European Institute of Oncology

Enrollment

45 participants

Start Date

Mar 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Triple-negative breast cancer (TNBC) is among the most aggressive and lethal types of breast cancer, and currently available therapies have an unsatisfactory impact on patients' survival. The primary aim of this clinical trial is to evaluate efficacy in terms of Overall Response Rate (ORR) of atezolizumab plus cyclophosphamide and vinorelbine in first line patients with unresectable locally advanced or metastatic TNBC patients, previously treated with anti-programmed cell death ligand-1 (PD-L1) or anti-programmed cell death-1 (PD-1) - containing regimens, in the neoadjuvant/adjuvant setting.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing atezolizumab (an immunotherapy drug) combined with chemotherapy as a treatment for people with metastatic triple-negative breast cancer (TNBC) — a type of breast cancer that lacks three common hormone receptors and tends to be harder to treat. Specifically, this is for patients whose tumours express a marker called PD-L1 and who have already received immunotherapy in an earlier treatment setting. **You may be eligible if...** - You have confirmed metastatic triple-negative breast cancer (TNBC) that tests PD-L1 positive - You previously received an anti-PD-1/PD-L1 immunotherapy in an earlier treatment stage (neoadjuvant or adjuvant) - You have not yet received chemotherapy for your metastatic disease - You are not a candidate for surgery **You may NOT be eligible if...** - Your cancer is not TNBC or does not express PD-L1 - You have already received chemotherapy for metastatic breast cancer - You have serious autoimmune conditions or organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab in combination with Cyclophosphamide and Vinorelbine

Patients will receive Atezolizumab in combination with Cyclophosphamide and Vinorelbine in 28-day cycles


Locations(5)

Fondazione IRCCS San Gerardo Dei Tintori

Monza, Monza, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Roma, Italy

Azienda Sanitaria Locale Br

Brindisi, Italy

European Institute of Oncology

Milan, Italy

View Full Details on ClinicalTrials.gov

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NCT06690840


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