AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer

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

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

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