Actively Recruiting
Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients
Led by European Institute of Oncology · Updated on 2026-01-05
45
Participants Needed
5
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Locally advanced or metastatic triple-negative breast cancer confirmed by biopsy
- Tumors must be PD-L1 positive with immune cells over 1% using Ventana SP142 test
- Previous treatment with anti-PD-1 or anti-PD-L1 therapy during early-stage treatment
- No prior chemotherapy, targeted therapy, or immunotherapy for advanced or metastatic disease
- Tumor tissue available for biopsies
- Expected survival longer than 3 months
- Age 18 years or older
- Measurable or evaluable metastatic disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate kidney and liver function
You will not qualify if you...
- Patients with newly diagnosed metastatic TNBC or who have received one or more systemic therapies for advanced disease
- Immune system deficiency or use of steroids or immunosuppressive therapy within 7 days before joining
- Active tuberculosis infection
- Allergic reaction to anti-PD-L1 antibodies or their ingredients
- Active autoimmune disease
- History of non-infectious pneumonitis
- Active infections requiring treatment
- Known HIV infection
- Active hepatitis B or hepatitis C infection
- Received live vaccines within 30 days
- Presence of bone or brain metastases
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Fondazione IRCCS San Gerardo Dei Tintori
Monza, Monza, Italy, 20900
Actively Recruiting
2
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, Italy, 00168
Not Yet Recruiting
3
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, Italy, 00168
Not Yet Recruiting
4
Azienda Sanitaria Locale Br
Brindisi, Italy
Not Yet Recruiting
5
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
Research Team
E
Elisabetta Munzone, MD
CONTACT
M
Mara Negri
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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