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

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ClinicalTrials.gov Identifier: NCT03147040
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Tracking Information
First Submitted Date  ICMJE May 4, 2017
First Posted Date  ICMJE May 10, 2017
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE November 2, 2017
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
Number of patients free of progression at 6 months [ Time Frame: At 6 months ]
Progression as defined by RECST 1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
  • Number of patients free of progression at 6 months in the IR profile subgroup [ Time Frame: 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 [ Time Frame: At 6 months ]
    as defined by retrospective gene expression profiling
  • Number of patients free of progression at 12 months [ Time Frame: At 12 months ]
    as defined by RECIST 1.1
  • Objective Response Rate [ Time Frame: Assessed up to 60 months ]
    Number of patients with a partial or complete response
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Assessed up to one month after end of treatment ]
    Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03
  • Overall Survival [ Time Frame: Assessed up to 60 months ]
    time from start treatment to death from any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer
Official Title  ICMJE AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Carboplatin
    Chemotherapy treatment with carboplatin and atezolizumab
  • Drug: Atezolizumab
    Chemotherapy treatment with carboplatin and atezolizumab
Study Arms  ICMJE 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
Interventions:
  • Drug: Carboplatin
  • Drug: Atezolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2029
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marleen Kok, MD +3120512 ext 9111 m.kok@nki.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03147040
Other Study ID Numbers  ICMJE M17GEL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: to be decided
Responsible Party The Netherlands Cancer Institute
Study Sponsor  ICMJE The Netherlands Cancer Institute
Collaborators  ICMJE Roche Pharma AG
Investigators  ICMJE
Principal Investigator: Marleen Kok, MD NKI-AvL
PRS Account The Netherlands Cancer Institute
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP