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At interim analysis insufficient benefit was observed to continu the study
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Chemotherapy treatment with carboplatin and atezolizumab |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients free of progression at 6 months | Progression as defined by RECST 1.1 | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients free of progression at 6 months in the IR profile subgroup | as defined by retrospective gene expression profiling | At 6 months |
| Number of patients free of progression at 6 months in the non- IR profile subgroup |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marleen Kok, MD | NKI-AvL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoni van Leeuwenhoek | Amsterdam | 1066 CX | Netherlands | |||
| UMCG |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37038006 | Derived | 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. |
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to be decided
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Atezolizumab |
| Drug |
Chemotherapy treatment with carboplatin and atezolizumab |
|
as defined by retrospective gene expression profiling
| At 6 months |
| Number of patients free of progression at 12 months | as defined by RECIST 1.1 | At 12 months |
| Objective Response Rate | Number of patients with a partial or complete response | 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 | Assessed up to one month after end of treatment |
| Overall Survival | time from start treatment to death from any cause | Assessed up to 60 months |
| Groningen |
| 9713 GZ |
| Netherlands |
| Maastricht University Medical Center | Maastricht | Netherlands |
| Erasmus Medical Center Cancer Institute | Rotterdam | 3015CE | Netherlands |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |