NL-OMON48948
Completed
Phase 2
AssessinG Efficacy of carboplatin and ATezOlizumab in metastatic Lobular breast cancer: GELATO-trial - GELATO
ederlands Kanker Instituut0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ederlands Kanker Instituut
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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 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
- •\* 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
Outcomes
Primary Outcomes
Not specified
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