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

Sponsor
The Netherlands Cancer Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT03147040
Collaborator
Roche Pharma AG (Industry)
23
4
1
55.9
5.8
0.1

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
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 :
Nov 2, 2017
Actual Primary Completion Date :
May 1, 2022
Actual Study Completion Date :
Jul 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients free of progression at 6 months [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 [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 [At 6 months]

    as defined by retrospective gene expression profiling

  3. Number of patients free of progression at 12 months [At 12 months]

    as defined by RECIST 1.1

  4. Objective Response Rate [Assessed up to 60 months]

    Number of patients with a partial or complete response

  5. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [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 [Assessed up to 60 months]

    time from start treatment to death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antoni van Leeuwenhoek Amsterdam Netherlands 1066 CX
2 UMCG Groningen Netherlands 9713 GZ
3 Maastricht University Medical Center Maastricht Netherlands
4 Erasmus Medical Center Cancer Institute Rotterdam Netherlands 3015CE

Sponsors and Collaborators

  • The Netherlands Cancer Institute
  • Roche Pharma AG

Investigators

  • Principal Investigator: Marleen Kok, MD, NKI-AvL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT03147040
Other Study ID Numbers:
  • M17GEL
First Posted:
May 10, 2017
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022