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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Carboplatin
Atezolizumab
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Lobular, Metastatic or incurable locally advanced cancer, Disease progression on endocrine therapy in advanced setting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Antoni van Leeuwenhoek
  • UMCG
  • Maastricht University Medical Center
  • Erasmus Medical Center Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carboplatin/Atezolizumab

Arm Description

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

Outcomes

Primary Outcome Measures

Number of patients free of progression at 6 months
Progression as defined by RECST 1.1

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2017
Last Updated
July 15, 2022
Sponsor
The Netherlands Cancer Institute
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT03147040
Brief Title
AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer
Acronym
GELATO
Official Title
AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
At interim analysis insufficient benefit was observed to continu the study
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
Roche Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Lobular, Metastatic or incurable locally advanced cancer, Disease progression on endocrine therapy in advanced setting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carboplatin/Atezolizumab
Arm Type
Experimental
Arm Description
Carboplatin AUC=1.5, weekly schedule, maximum 12 administrations Atezolizumab, 1200 mg flat dose, 3-weekly schedule, starting after two administrations of carboplatin
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Chemotherapy treatment with carboplatin and atezolizumab
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Chemotherapy treatment with carboplatin and atezolizumab
Primary Outcome Measure Information:
Title
Number of patients free of progression at 6 months
Description
Progression as defined by RECST 1.1
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Number of patients free of progression at 6 months in the IR profile subgroup
Description
as defined by retrospective gene expression profiling
Time Frame
At 6 months
Title
Number of patients free of progression at 6 months in the non- IR profile subgroup
Description
as defined by retrospective gene expression profiling
Time Frame
At 6 months
Title
Number of patients free of progression at 12 months
Description
as defined by RECIST 1.1
Time Frame
At 12 months
Title
Objective Response Rate
Description
Number of patients with a partial or complete response
Time Frame
Assessed up to 60 months
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
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
Title
Overall Survival
Description
time from start treatment to death from any cause
Time Frame
Assessed up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marleen Kok, MD
Organizational Affiliation
NKI-AvL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antoni van Leeuwenhoek
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
UMCG
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Facility Name
Erasmus Medical Center Cancer Institute
City
Rotterdam
ZIP/Postal Code
3015CE
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
to be decided

Learn more about this trial

AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer

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