Clinical trial · Interventional
AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer
AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial
NCT03147040CI-TRIAL-00059732GELATOterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): At interim analysis insufficient benefit was observed to continu the study
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carboplatin/Atezolizumab
- description
- Carboplatin AUC=1.5, weekly schedule, maximum 12 administrations Atezolizumab, 1200 mg flat dose, 3-weekly schedule, starting after two administrations of carboplatin
- interventionNames
- Drug: Carboplatin
- Drug: Atezolizumab
Primary outcomes (1)
- measure
- Number of patients free of progression at 6 months
- timeFrame
- At 6 months
- description
- Progression as defined by RECST 1.1
Secondary outcomes (6)
- measure
- Number of patients free of progression at 6 months in the IR profile subgroup
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVoorwerk 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 37038006