AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer

Breast Cancer Clinical Trial

— GELATO  

Official title:

AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03147040
• Other study ID #: M17GEL
• Status: Terminated
• Phase: Phase 2
• Start date: November 2, 2017
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Carboplatin
Chemotherapy treatment with carboplatin and atezolizumab
• Atezolizumab
Chemotherapy treatment with carboplatin and atezolizumab

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoek	Amsterdam
Netherlands	UMCG	Groningen
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus Medical Center Cancer Institute	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Roche Pharma AG

Country where clinical trial is conducted

Netherlands, 

Outcome

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