lobular breast cancer metastatic
Conditions
Interventions
Carboplatin AUC 1.5 , intravenous administration, weekly schedule, maximum 12
administrations (no steroids necessary).
After two administrations of carboplatin, atezolizumab (1200 mg flat dose) will
breastcancer
lobular
metastatic
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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 or aberrant staining (IHC) on a biopsy of a metastatic lesion. * Estrogen receptor expression of at least 10% on a metastatic lesion (independent of progesterone receptor expression and HER2 expression) * Metastatic lesion accessible for histological biopsies * Evidence of progression of disease * A maximum of two lines of palliative chemotherapy. Carboplatin pretreatment is allowed, as long as no progression was observed and the last dose was administered 6 months before starting study treatment * WHO performance status of 0 or 1 * Evaluable disease or measurable according to RECIST 1.1
Exclusion criteria
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 |
|---|---|
| Proportion of patients who remain free of progression at 6 months. Progression as defined by RECIST 1.1 will be used. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Proportion of patients free of progression (RECIST 1.1 at 6 months in the IR-profile subgroup vs the non-IR-subgroup as defined by gene expression profiling * Proportion of patients who remain free of progression at 12 months. Progression as defined by RECIST 1.1 will be used. * Progression as defined by iRECIST * Overall survival * Percentage of patients with toxicity (according to CTCAE v4.03) and immune-related toxicity defined as the Adverse Events of Special Interest (AESI's) for atezolizumab * Objective response rate (RECIST 1.1) | — |
Countries
The Netherlands
Outcome results
None listed