Atezolizumab with cyclophosphamide and vinorelbine for metastatic triple-negative breast cancer
Official title: 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
Run by European Institute of Oncology · NCT06690840 · Data updated 2026-11-12
This trial will test whether adding atezolizumab to the chemotherapy drugs cyclophosphamide and vinorelbine helps people with PD-L1–positive metastatic triple-negative breast cancer who are starting first-line treatment after prior PD-1/PD-L1 therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, atezolizumab, cyclophosphamide |
| Locations | 5 sites (Monza, Monza and 4 other locations) |
| Status | Recruiting |
| Started | March 6, 2025 |
| Main results expected | December 15, 2026 |
| Study ends | February 15, 2027 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT06690840 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with unresectable locally advanced or metastatic PD-L1–positive (IC >1% by Ventana SP142) triple-negative breast cancer who received prior PD-1/PD-L1 therapy in the neoadjuvant/adjuvant setting, have measurable disease, ECOG 0–1, adequate organ function, and accessible tissue for biopsies are the intended participants.
✕Probably not a fit
Patients with PD-L1–negative tumors, those who have already received systemic therapy for metastatic disease, or those with poor performance status or significant organ dysfunction are unlikely to benefit from this regimen.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 trial gives atezolizumab together with cyclophosphamide and vinorelbine to adults with PD-L1–positive, unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease but had PD-1/PD-L1 drugs in the neoadjuvant/adjuvant setting. The primary endpoint is overall response rate (ORR) by RECIST 1.1, and secondary endpoints include duration of response, progression-free survival, overall survival, and safety. Eligible patients must have measurable disease, ECOG 0–1, adequate organ function, and tissue accessible for biopsies, with treatment continued until progression or unacceptable toxicity. The regimen was chosen based on complementary preclinical TNBC models aiming to identify an optimal chemotherapy backbone to pair with checkpoint inhibition.
Why it matters
Potential benefit: If successful, this combination could increase tumor response rates and prolong the time patients live without disease progression compared with current options.
How similar studies have gone: Previous randomized trials combining anti–PD-1/PD-L1 agents with chemotherapy in TNBC have shown benefit in some settings (for example atezolizumab plus nab‑paclitaxel in PD-L1–positive patients) but results have been mixed and the optimal chemotherapy partner remains uncertain.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Fondazione IRCCS San Gerardo Dei Tintori
Monza, Monza, Italy Recruiting -
European Institute of Oncology
Milan, Italy Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, Italy Not yet recruiting -
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, Italy Not yet recruiting -
Azienda Sanitaria Locale Br
Brindisi, Italy Not yet recruiting
Study contacts
- Principal investigator: Elisabetta Munzone, MD — European Istitute of Oncology
- Study coordinator: Elisabetta Munzone, MD
- Email: elisabetta.munzone@ieo.it
- Phone: +39 0257489405
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.