Testing atezolizumab with chemotherapy in advanced triple negative breast cancer
Tests atezolizumab with two chemotherapy drugs in adults with advanced triple negative breast cancer.
Plain-language title generated from the registry record
Registry title: Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients
Key facts
- Where
- Brindisi, Milan, Monza, and Roma, ItalySee the 4 sites
- Phase
- Phase 2
Where in Italy
- Azienda Sanitaria Locale BrBrindisi, ItalyNot yet recruiting
- European Institute of OncologyMilan, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- European Institute of Oncology
- Trial code
- NCT06690840
- Record updated
- 5 January 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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]); Bone or brain metastases.