AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer

Phase 2TerminatedNCT03147040

The Netherlands Cancer Institute23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

CarboplatinDRUG

Chemotherapy treatment with carboplatin and atezolizumab

AtezolizumabDRUG

Chemotherapy treatment with carboplatin and atezolizumab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Antoni van Leeuwenhoek

Amsterdam, Netherlands

UMCG

Groningen, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Erasmus Medical Center Cancer Institute

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Number of patients free of progression at 6 months

Progression as defined by RECST 1.1

Time frame: At 6 months

Secondary Outcomes

Number of patients free of progression at 6 months in the IR profile subgroup

as defined by retrospective gene expression profiling

Time frame: At 6 months

Number of patients free of progression at 6 months in the non- IR profile subgroup

as defined by retrospective gene expression profiling

Time frame: At 6 months

Number of patients free of progression at 12 months

as defined by RECIST 1.1

Time frame: At 12 months

Objective Response Rate

Number of patients with a partial or complete response

Time frame: Assessed up to 60 months

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03

Time frame: Assessed up to one month after end of treatment

Overall Survival

time from start treatment to death from any cause

Time frame: Assessed up to 60 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.