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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 : November 17, 2017
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Carboplatin Drug: Atezolizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. Number of patients free of progression at 6 months [ Time Frame: At 6 months ]
    Progression as defined by RECST 1.1


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Number of patients free of progression at 12 months [ Time Frame: At 12 months ]
    as defined by RECIST 1.1

  4. Objective Response Rate [ Time Frame: Assessed up to 60 months ]
    Number of patients with a partial or complete response

  5. 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

  6. Overall Survival [ Time Frame: Assessed up to 60 months ]
    time from start treatment to death from any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147040


Contacts
Contact: Marleen Kok, MD +3120512 ext 9111 m.kok@nki.nl

Locations
Netherlands
Antoni van Leeuwenhoek Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Marleen Kok, MD    +3120512 ext 9111    m.kok@nki.nl   
Contact: Ingrid AM Mandjes, MSc    +3120512 ext 9111    i.mandjes@nki.nl   
Principal Investigator: Marleen Kok, MD         
UMCG Not yet recruiting
Groningen, Netherlands, 9713 GZ
Contact: C Schroder, MD         
Principal Investigator: C Schroder, MD         
Maastricht University Medical Center Not yet recruiting
Maastricht, Netherlands
Contact: V Tjan-Heijnen, Prof. MD         
Principal Investigator: V Tjan-Heijnen, Prof. MD         
Erasmus Medical Center Cancer Institute Not yet recruiting
Rotterdam, Netherlands, 3015CE
Contact: A Jager, MD         
Principal Investigator: A Jager, MD         
Sponsors and Collaborators
The Netherlands Cancer Institute
Roche Pharma AG
Investigators
Principal Investigator: Marleen Kok, MD NKI-AvL

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03147040     History of Changes
Other Study ID Numbers: M17GEL
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be decided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Netherlands Cancer Institute:
Lobular
Metastatic or incurable locally advanced cancer
Disease progression on endocrine therapy in advanced setting

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Atezolizumab
Carboplatin
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs