Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients
NCT ID: NCT06690840
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2025-03-06
2027-02-15
Brief Summary
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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.
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Detailed Description
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The association of checkpoint inhibitors (CIs) such as anti-PD-L1 with chemotherapy has shown some encouraging results in randomized clinical trials enrolling TNBC patients either in the early (neo-adjuvant) or in the advanced/metastatic setting, but there has been no clear evidence of what should be considered the best chemotherapy backbone to be associated with CIs.
What could be considered the most promising combinatorial regimen of chemotherapy plus anti-PDL1 was defined using two complementary TNBC models at the preclinical level. The present phase II study will investigate overall response rate (ORR) as primary endpoint in first line metastatic TNBC patients treated with this investigational combination comprising atezolizumab (A) Vinorelbine (V), and Cyclophosphamide (C).
Secondary objectives will investigate duration of response (DOR), progression-free survival (PFS) and overall survival (OS) and the safety of the study regimen.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Atezolizumab plus Cyclophosphamide and Vinorelbine
Atezolizumab 840 mg intravenous (IV) on Days 1 and 15 of every 28-day cycle in combination with Cyclophosphamide 300 mg/m2 IV on Days 1 ,8,15, 21 of every 28-day cycle and Vinorelbine 30 mg per os (PO) on Days 1, 3, 5 every week of every 28-day cycle
Atezolizumab in combination with Cyclophosphamide and Vinorelbine
Patients will receive Atezolizumab in combination with Cyclophosphamide and Vinorelbine in 28-day cycles
Interventions
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Atezolizumab in combination with Cyclophosphamide and Vinorelbine
Patients will receive Atezolizumab in combination with Cyclophosphamide and Vinorelbine in 28-day cycles
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Elisabetta Munzone, MD
Role: PRINCIPAL_INVESTIGATOR
European Istitute of Oncology
Francesco Bertolini
Role: PRINCIPAL_INVESTIGATOR
European Istitute of Oncology
Locations
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Fondazione IRCCS San Gerardo Dei Tintori
Monza, Monza, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, Italy
Azienda Sanitaria Locale Br
Brindisi, , Italy
European Institute of Oncology
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UID 2686
Identifier Type: -
Identifier Source: org_study_id
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