Breast Cancer
Conditions
Keywords
Lobular, Metastatic or incurable locally advanced cancer, Disease progression on endocrine therapy in advanced setting
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
Interventions
DRUGCarboplatin
Chemotherapy treatment with carboplatin and atezolizumab
DRUGAtezolizumab
Chemotherapy treatment with carboplatin and atezolizumab
Sponsors
Roche Pharma AG
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients free of progression at 6 months | At 6 months | Progression as defined by RECST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of patients free of progression at 6 months in the IR profile subgroup | At 6 months | as defined by retrospective gene expression profiling |
| 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 |
| Objective Response Rate | Assessed up to 60 months | Number of patients with a partial or complete response |
Countries
Netherlands
Outcome results
None listed