Breast Cancer Clinical Trial
— GELATOOfficial title:
AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial
Verified date | July 2022 |
Source | The Netherlands Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC
Status | Terminated |
Enrollment | 23 |
Est. completion date | July 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Antoni van Leeuwenhoek | Amsterdam | |
Netherlands | UMCG | Groningen | |
Netherlands | Maastricht University Medical Center | Maastricht | |
Netherlands | Erasmus Medical Center Cancer Institute | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute | Roche Pharma AG |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients free of progression at 6 months | Progression as defined by RECST 1.1 | At 6 months | |
Secondary | Number of patients free of progression at 6 months in the IR profile subgroup | as defined by retrospective gene expression profiling | At 6 months | |
Secondary | 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 | |
Secondary | Number of patients free of progression at 12 months | as defined by RECIST 1.1 | At 12 months | |
Secondary | Objective Response Rate | Number of patients with a partial or complete response | Assessed up to 60 months | |
Secondary | 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 | |
Secondary | Overall Survival | time from start treatment to death from any cause | Assessed up to 60 months |
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