Breast CancerPhase 2GELATONCT03147040
AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer
A Phase 2 study testing Carboplatin and Atezolizumab in people with Breast Cancer, run by The Netherlands Cancer Institute at 4 sites in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Carboplatin and Atezolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesNetherlands
- Study dates
- 2 Nov 2017to 1 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Antoni van Leeuwenhoek
Amsterdam, 1066 CX
UMCG
Groningen, 9713 GZ
Maastricht University Medical Center
Maastricht
Erasmus Medical Center Cancer Institute
Rotterdam, 3015CE
About this study
Official title: AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial
This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC
- Conditions
- Breast Cancer
- Being tested
- Carboplatin, Atezolizumab
- Keywords
- Lobular, Metastatic or incurable locally advanced cancer, Disease progression on endocrine therapy in advanced setting
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Chemotherapy treatment with carboplatin and atezolizumab
AtezolizumabDrug
Chemotherapy treatment with carboplatin and atezolizumab
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Carboplatin; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients free of progression at 6 months
Progression as defined by RECST 1.1
Measured: At 6 months
Secondary outcomes (6)
Number of patients free of progression at 6 months in the IR profile subgroup
as defined by retrospective gene expression profiling
Measured: At 6 months
Number of patients free of progression at 6 months in the non- IR profile subgroup
as defined by retrospective gene expression profiling
Measured: At 6 months
Number of patients free of progression at 12 months
as defined by RECIST 1.1
Measured: At 12 months
Objective Response Rate
Number of patients with a partial or complete response
Measured: Assessed up to 60 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03
Measured: Assessed up to one month after end of treatment
Overall Survival
time from start treatment to death from any cause
Measured: Assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start2 Nov 2017
- Primary completion1 May 2022
- Study completion1 Jul 2022
Why it stopped: At interim analysis insufficient benefit was observed to continu the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Marleen Kok, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147040
- Sponsor's protocol ID
- M17GEL
- Acronym
- GELATO
- Status last verified
- Jul 2022
- First submitted
- 4 May 2017
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be decided
Publications
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.
PubMed 37038006
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial
- ClinicalTrials.gov ID
- NCT03147040
- Acronym / sponsor ID
- GELATO / M17GEL
- Conditions
- Breast Cancer
- Keywords
- Lobular, Metastatic or incurable locally advanced cancer, Disease progression on endocrine therapy in advanced setting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At interim analysis insufficient benefit was observed to continu the study
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin/Atezolizumab | Experimental | Drug: Carboplatin, Drug: AtezolizumabCarboplatin AUC=1.5, weekly schedule, maximum 12 administrations Atezolizumab, 1200 mg flat dose, 3-weekly schedule, starting after two administrations of carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinChemotherapy treatment with carboplatin and atezolizumab | Drug | Carboplatin/Atezolizumab |
| AtezolizumabChemotherapy treatment with carboplatin and atezolizumab | Drug | Carboplatin/Atezolizumab |
Primary outcome
Number of patients free of progression at 6 months
Time frame: At 6 months
Progression as defined by RECST 1.1
6 secondary outcomes
Number of patients free of progression at 6 months in the IR profile subgroup
Time frame: At 6 months
Number of patients free of progression at 6 months in the non- IR profile subgroup
Time frame: At 6 months
Number of patients free of progression at 12 months
Time frame: At 12 months
Objective Response Rate
Time frame: Assessed up to 60 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Assessed up to one month after end of treatment
Overall Survival
Time frame: Assessed up to 60 months
Results and safety
The study was stopped early (reason given: At interim analysis insufficient benefit was observed to continu the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 37038006Voorwerk 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.
- Individual participant dataSharing planned: Undecided. to be decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marleen Kok, MD principal investigator
The Netherlands Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin and Atezolizumab in people with Breast Cancer, run by The Netherlands Cancer Institute at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: At interim analysis insufficient benefit was observed to continu the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients free of progression at 6 months (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03147040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.