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
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.
• Signed Informed Consent Form
• Patients with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PR\] expression) PD-L1+ (Immune Cell \>1% using Ventana SP142 assay), not amenable to surgical therapy
• Locally advanced or metastatic TNBC, who have received an anti-PD-1/PD-L1 containing regimen in the neoadjuvant/adjuvant setting
• No prior chemotherapy or targeted systemic therapy (including endocrine therapy) or immunotherapy for inoperable locally advanced or metastatic TNBC
• Tissue accessible for biopsies
• Expected survival of \> 3 months
• Female or male subject ≥18 years
• Have measurable/evaluable metastatic disease (RECIST 1.1 criteria)
• Performance status 0-1 on Eastern Cooperative Oncology Group Performance Status (ECOG PS)
• Demonstrate adequate organ (kidney, liver) function