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

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Nov 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with metastatic triple-negative breast cancer (TNBC), a particularly aggressive form of breast cancer. The trial will test the combination of atezolizumab—a type of immunotherapy—and two chemotherapy drugs, cyclophosphamide and vinorelbine. Researchers want to see how well this combination works in patients whose cancer has not improved with previous treatments that targeted specific immune pathways.

To participate in the trial, patients must have a confirmed diagnosis of locally advanced or metastatic TNBC that cannot be treated with surgery. They should also have previously received certain types of immunotherapy, but not chemotherapy or targeted treatments for their advanced cancer. Participants should be at least 18 years old, have measurable cancer, and be in good overall health. If eligible, participants will receive the study treatment and be monitored for how well it works and any side effects. The trial is not yet recruiting, but it aims to provide new hope for patients facing this challenging cancer type.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Patients with de novo metastatic TNBC OR those who have received 1 or more chemotherapy or targeted systemic therapy (including endocrine therapy) or immunotherapy regimens for advanced disease
• • Immunodeficiency or systemic steroid therapy/immunosuppressive therapy within 7 days prior to study entry
• • Known history of active Bacillus Tuberculosis (TBC)
• • Hypersensitivity to anti- PD-L1 antibodies or its excipients
• • Active autoimmune disease
• • Known history of non-infectious pneumonitis
• • Active infection requiring systemic therapy
• • Known history of Human Immunodeficiency Virus (HIV)
• • Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\])
• • Live vaccine within 30 days
• • Bone or brain metastases