GELATO: AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer
Study Details
Study Description
Brief Summary
This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Carboplatin/Atezolizumab 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
Chemotherapy treatment with carboplatin and atezolizumab
Drug: Atezolizumab
Chemotherapy treatment with carboplatin and atezolizumab
|
Outcome Measures
Primary Outcome Measures
- Number of patients free of progression at 6 months [At 6 months]
Progression as defined by RECST 1.1
Secondary Outcome Measures
- Number of patients free of progression at 6 months in the IR profile subgroup [At 6 months]
as defined by retrospective gene expression profiling
- Number of patients free of progression at 6 months in the non- IR profile subgroup [At 6 months]
as defined by retrospective gene expression profiling
- Number of patients free of progression at 12 months [At 12 months]
as defined by RECIST 1.1
- Objective Response Rate [Assessed up to 60 months]
Number of patients with a partial or complete response
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [Assessed up to one month after end of treatment]
Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03
- Overall Survival [Assessed up to 60 months]
time from start treatment to death from any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed and written informed consent
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Age 18 year or older
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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.
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Metastatic lesion accessible for histological biopsies
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Evidence of progression of disease
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A maximum of two lines of palliative chemotherapy
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WHO performance status of 0 or 1
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Evaluable disease or measurable according to RECIST 1.1
Exclusion Criteria:
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Leptomeningeal disease localization
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History of having received other anticancer therapies within 2 weeks of start of the study drug
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History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression
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Prior treatment with immune checkpoint blockade
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Live vaccine within 2 weeks prior to start of study
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Active other cancer
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Active hepatitis B
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Antoni van Leeuwenhoek | Amsterdam | Netherlands | 1066 CX | |
2 | UMCG | Groningen | Netherlands | 9713 GZ | |
3 | Maastricht University Medical Center | Maastricht | Netherlands | ||
4 | Erasmus Medical Center Cancer Institute | Rotterdam | Netherlands | 3015CE |
Sponsors and Collaborators
- The Netherlands Cancer Institute
- Roche Pharma AG
Investigators
- Principal Investigator: Marleen Kok, MD, NKI-AvL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M17GEL