Clinical trial · Interventional
Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer
A Phase II With 2 Parallel Cohorts Clinical Trial Targeting Estrogen Receptor Negative or PAM50 Non-luminal Disease With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer - ATREZZO Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Immune checkpoint inhibitors given in monotherapy in advanced breast cancer have shown modest benefit in first-line, but very limited efficacy in later lines. Thus, combination therapies are needed. Response following anti-PD1/PD-L1 monotherapy is associated with large survival benefit in the advanced setting. Previous studies of the intrinsic subtypes have shown that Basal-like and HER2-E are associated with higher expression of immune-related genes or higher infiltration of stromal tumor infiltrating lymphocytes compared to the luminal subtypes. Immune infiltration in BC is associated with chemo/antiHER2 responsiveness and potentially benefit from anti-PD-1/PD-L1 inhibitors. In addition, one emerging biomarker of response to anti-PD-1 therapy is the tumor mutational burden (I.e. the total number of mutations per coding area of a tumor genome). The HER2-E and Basal-like profiles have been associated with high mutational burden. A range of studies have been initiated including several phase II/III studies evaluating atezolizumab in combination with different chemotherapeutic compounds routinely used in breast cancer, but none with predefined biomarker beyond the expression of PD-L1 by IHC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab + Trastuzumab + Vinorelbine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Atezolizumab in combination with Trastuzumab and Vinorelbine
- interventionNames
- Drug: Atezolizumab + Trastuzumab + Vinorelbine
Primary outcomes (1)
- measure
- Overall Response rate
- timeFrame
- until disease progression or up to 2 years after treatment ends
- description
- the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Secondary outcomes (11)
- measure
- Overall Response rate in PD-L1+ patients
- timeFrame
- until disease progression or up to 2 years after treatment ends
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female (Premenopausal or postmenopausal women) * ECOG 0 to 2 * Histologically confirmed adenocarcinoma of the breast, metastatic or unresectable locally advanced. * All patients must have received at least trastuzumab and other anti-HER2 ADCs (including but not limited to T-DM1). * Measurable disease according to RECIST 1.1 criteria. * Adequate organ function * Baseline LVEF ≥50% * Participants with asymptomatic brain metastases are eligible. Exclusion Criteria: * Treatment with any investigational anticancer drug within 14 days of the start of study treatment. * Patient has received Vinorelbine or any other vinca alkaloids previously immediately prior to initiate study treatment. * History of other malignant tumors in the past 3 years * Known or suspected leptomeningeal disease (LMD)/ poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases. * Symptomatic hypercalcemia requiring treatment with bisphosphonates in the 14 days prior to inclusion * Cardiopulmonary dysfunction * Any other severe, uncontrolled * Major surgery in the 28 days prior to enrolment * Infection with HIV or active Hepatitis B and/or Hepatitis C. * History of trastuzumab intolerance, including grade 3-4 infusion reaction or hypersensitivity. * Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation * History of autoimmune disease, * Prior allogeneic stem cell or solid organ transplantation * History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan. (Note: History of radiation pneumonitis in the radiation field \[fibrosis\] is permitted.) * Active tuberculosis * Receipt of a live, attenuated vaccine within 4 weeks prior to enrollment * Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or immune checkpoint targeting agents * Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \[IL\]-2) within 4 weeks or five half-lives of the drug prior to enrolment * Treatment with systemic immunosuppressive medications within 2 weeks prior to enrolment, or anticipated requirement for systemic immunosuppressive medications during the trial.
References
Publications (0)
Data not yet available