Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients

NCT06690840 | Recruiting Phase 2

• 1 other identifier: UID 2686
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

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.

Conditions

Triple Negative Breast Cancer

Keywords

Triple Negative Breast Cancer; PD-L1-positive; Locally advanced or metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Rate of subjects who achieve either a confirmed Complete Response (CR) or Partial Response (PR)

  30 months

Secondary Outcomes (3)

• Progression-free survival (PFS)

  30 months

• Overall survival (OS)

  30 months

• Duration on response (DoR)

  30 months

Study Arms (1)

Atezolizumab plus Cyclophosphamide and Vinorelbine

EXPERIMENTAL

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

Drug: Atezolizumab in combination with Cyclophosphamide and Vinorelbine

Interventions

Atezolizumab in combination with Cyclophosphamide and Vinorelbine DRUG

Patients will receive Atezolizumab in combination with Cyclophosphamide and Vinorelbine in 28-day cycles

Atezolizumab plus Cyclophosphamide and Vinorelbine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (5)

Fondazione IRCCS San Gerardo Dei Tintori

Monza, Monza, 20900, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Roma, 00168, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Roma, 00168, Italy

NOT YET RECRUITING

Azienda Sanitaria Locale Br

Brindisi, Italy

NOT YET RECRUITING

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

atezolizumab; Cyclophosphamide; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Elisabetta Munzone, MD

  European Istitute of Oncology

  PRINCIPAL INVESTIGATOR

• Francesco Bertolini

  European Istitute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabetta Munzone, MD

CONTACT

+39 0257489405; elisabetta.munzone@ieo.it

Mara Negri

CONTACT

+39 0257489536; mara.negri@ieo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, phase II, single arm, multicenter study

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: January 5, 2026

Record last verified: 2026-01

Locations

IT (5)