AssessinG Efficacy of carboplatin and ATezOlizumab in metastatic Lobular breast cancer: GELATO-trial

Phase 2

Completed

Conditions: lobular breast cancer
metastatic
10006291

Registration Number: NL-OMON48948

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of patients who remain free of progression at 6 months. Progression<br /><br>as defined by RECIST 1.1 will be used.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Proportion of patients free of progression (RECIST 1.1 at 6 months in the<br /><br>IR-profile subgroup vs the non-IR-subgroup as defined by gene expression<br /><br>profiling<br /><br>* Proportion of patients who remain free of progression at 12 months.<br /><br>Progression as defined by RECIST 1.1 will be used.<br /><br>* Progression as defined by iRECIST<br /><br>* Overall survival<br /><br>* Percentage of patients with toxicity (according to CTCAE v4.03) and<br /><br>immune-related toxicity defined as the Adverse Events of Special Interest<br /><br>(AESI's) for atezolizumab<br /><br>* Objective response rate (RECIST 1.1)</p><br>