NCT03147040

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2017

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

November 2, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

4.5 years

First QC Date

May 4, 2017

Last Update Submit

July 15, 2022

Conditions

Breast Cancer

Keywords

LobularMetastatic or incurable locally advanced cancerDisease progression on endocrine therapy in advanced setting

Outcome Measures

Primary Outcomes (1)

  • Number of patients free of progression at 6 months

    Progression as defined by RECST 1.1

    At 6 months

Secondary Outcomes (6)

  • Number of patients free of progression at 6 months in the IR profile subgroup

    At 6 months

  • Number of patients free of progression at 6 months in the non- IR profile subgroup

    At 6 months

  • Number of patients free of progression at 12 months

    At 12 months

  • Objective Response Rate

    Assessed up to 60 months

  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Assessed up to one month after end of treatment

  • +1 more secondary outcomes

Study Arms (1)

Carboplatin/Atezolizumab

EXPERIMENTAL

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

Drug: CarboplatinDrug: Atezolizumab

Interventions

CarboplatinDRUG

Chemotherapy treatment with carboplatin and atezolizumab

Carboplatin/Atezolizumab
AtezolizumabDRUG

Chemotherapy treatment with carboplatin and atezolizumab

Carboplatin/Atezolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Antoni van Leeuwenhoek

Amsterdam, 1066 CX, Netherlands

Location

UMCG

Groningen, 9713 GZ, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Erasmus Medical Center Cancer Institute

Rotterdam, 3015CE, Netherlands

Location

Related Publications (1)

  • Voorwerk L, Isaeva OI, Horlings HM, Balduzzi S, Chelushkin M, Bakker NAM, Champanhet E, Garner H, Sikorska K, Loo CE, Kemper I, Mandjes IAM, de Maaker M, van Geel JJL, Boers J, de Boer M, Salgado R, van Dongen MGJ, Sonke GS, de Visser KE, Schumacher TN, Blank CU, Wessels LFA, Jager A, Tjan-Heijnen VCG, Schroder CP, Linn SC, Kok M. PD-L1 blockade in combination with carboplatin as immune induction in metastatic lobular breast cancer: the GELATO trial. Nat Cancer. 2023 Apr;4(4):535-549. doi: 10.1038/s43018-023-00542-x. Epub 2023 Apr 10.

    PMID: 37038006DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Carboplatinatezolizumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Marleen Kok, MD

    NKI-AvL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 10, 2017

Study Start

November 2, 2017

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

NL(4)