NCT06690840 Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients
| NCT ID | NCT06690840 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | European Institute of Oncology |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2025-03-06 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Elisabetta Munzone, MD
PRINCIPAL INVESTIGATOR
European Istitute of Oncology
Frequently Asked Questions
Who can join the NCT06690840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06690840 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06690840 currently recruiting?
Yes, NCT06690840 is actively recruiting participants. Contact the research team at elisabetta.munzone@ieo.it for enrollment information.
Where is the NCT06690840 trial being conducted?
This trial is being conducted at Monza, Italy, Roma, Italy, Roma, Italy, Brindisi, Italy and 1 additional location.
Who is sponsoring the NCT06690840 clinical trial?
NCT06690840 is sponsored by European Institute of Oncology. The principal investigator is Elisabetta Munzone, MD at European Istitute of Oncology. The trial plans to enroll 45 participants.
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