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AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer

TerminatedPhase 2

Sponsor: The Netherlands Cancer Institute

Conditions: Breast Cancer

Interventions: Carboplatin, Atezolizumab

Countries: Netherlands

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 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

Locations (4)

Amsterdam, Netherlands
Groningen, Netherlands
Maastricht, Netherlands
Rotterdam, Netherlands