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

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

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

Conditions3

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