AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Carboplatin; Drug: Atezolizumab

• Registration Number: NCT03147040
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Study Start: 2017-11-02
• Primary Completion: 2022-05-01
• Status Verified: 2022-07
• Study Completion: 2022-07-01
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carboplatin/Atezolizumab	Carboplatin	Carboplatin AUC=1.5, weekly schedule, maximum 12 administrations Atezolizumab, 1200 mg flat dose, 3-weekly schedule, starting after two administrations of carboplatin
Carboplatin/Atezolizumab	Atezolizumab	Carboplatin AUC=1.5, weekly schedule, maximum 12 administrations Atezolizumab, 1200 mg flat dose, 3-weekly schedule, starting after two administrations of carboplatin

Primary Outcome Measures

Name	Time	Method
Number of patients free of progression at 6 months	At 6 months	Progression as defined by RECST 1.1

Secondary Outcome Measures

Name	Time	Method
Number of patients free of progression at 6 months in the IR profile subgroup	At 6 months	as defined by retrospective gene expression profiling
Number of patients free of progression at 6 months in the non- IR profile subgroup	At 6 months	as defined by retrospective gene expression profiling
Number of patients free of progression at 12 months	At 12 months	as defined by RECIST 1.1
Objective Response Rate	Assessed up to 60 months	Number of patients with a partial or complete response
Overall Survival	Assessed up to 60 months	time from start treatment to death from any cause
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Assessed up to one month after end of treatment	Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03

Trial Locations

Locations (4)

Erasmus Medical Center Cancer Institute; 🇳🇱 Rotterdam, Netherlands

Antoni van Leeuwenhoek; 🇳🇱 Amsterdam, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

UMCG; 🇳🇱 Groningen, Netherlands