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

Korábbi kezelés

• 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
• Live vaccine within 30 days

Más betegség

• 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])

Egyéb

• Bone or brain metastases

• 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