AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer (GELATO)

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

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 Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Carboplatin; Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Antoni van Leeuwenhoek
  • Groningen, Netherlands, 9713 GZ
    • UMCG
  • Maastricht, Netherlands
    • Maastricht University Medical Center
  • Rotterdam, Netherlands, 3015CE
    • Erasmus Medical Center Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carboplatin/Atezolizumab; Carboplatin AUC=1.5, weekly schedule, maximum 12 administrations Atezolizumab, 1200 mg flat dose, 3-weekly schedule, starting after two administrations of carboplatin	Drug: Carboplatin; Chemotherapy treatment with carboplatin and atezolizumab; Drug: Atezolizumab; Chemotherapy treatment with carboplatin and atezolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients free of progression at 6 months	Progression as defined by RECST 1.1	At 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients free of progression at 6 months in the IR profile subgroup	as defined by retrospective gene expression profiling	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	At 6 months
Number of patients free of progression at 12 months	as defined by RECIST 1.1	At 12 months
Objective Response Rate	Number of patients with a partial or complete response	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	Assessed up to one month after end of treatment
Overall Survival	time from start treatment to death from any cause	Assessed up to 60 months

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Roche Pharma AG
• Investigators: Principal Investigator: Marleen Kok, MD, NKI-AvL

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Lobular; Metastatic or incurable locally advanced cancer; Disease progression on endocrine therapy in advanced setting
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Carboplatin; Atezolizumab
• Other Study ID Numbers: M17GEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: to be decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No