AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer

Study Overview
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Brief Summary
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This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC

Official Title
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AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Atezolizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and written informed consent Age 18 year or older Metastatic or incurable locally advanced lobular breast cancer with confirmation of the lobular histology and E-cadherin loss on a biopsy of a metastatic lesion. Metastatic lesion accessible for histological biopsies Evidence of progression of disease A maximum of two lines of palliative chemotherapy WHO performance status of 0 or 1 Evaluable disease or measurable according to RECIST 1.1 Exclusion Criteria: Leptomeningeal disease localization History of having received other anticancer therapies within 2 weeks of start of the study drug History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression Prior treatment with immune checkpoint blockade Live vaccine within 2 weeks prior to start of study Active other cancer Active hepatitis B

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboplatin/Atezolizumab<br>Carboplatin AUC=1.5, weekly schedule, maximum 12 administrations Atezolizumab, 1200 mg flat dose, 3-weekly schedule, starting after two administrations of carboplatin | Drug: Carboplatin<br>* Chemotherapy treatment with carboplatin and atezolizumab<br>Drug: Atezolizumab<br>* Chemotherapy treatment with carboplatin and atezolizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients free of progression at 6 months | Progression as defined by RECST 1.1 | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients free of progression at 6 months in the IR profile subgroup | as defined by retrospective gene expression profiling | At 6 months | 
| Number of patients free of progression at 6 months in the non- IR profile subgroup | as defined by retrospective gene expression profiling | At 6 months | 
| Number of patients free of progression at 12 months | as defined by RECIST 1.1 | At 12 months | 
| Objective Response Rate | Number of patients with a partial or complete response | Assessed up to 60 months | 
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03 | Assessed up to one month after end of treatment | 
| Overall Survival | time from start treatment to death from any cause | Assessed up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lobular, Metastatic or incurable locally advanced cancer, Disease progression on endocrine therapy in advanced setting