"DEMETER": Milademetan and fulvestrant in GATA3-mutant, ER-positive, HER2-negative advanced or metastatic breast cancer patients: a multicenter phase II trial

Conditions

GATA3-mutant, ER-positive, HER2-negative advanced or metastatic breast cancer

Brief summary

The proportion of patients who have achieved either a confirmed complete or partial response, or stable disease for at least 24 weeks after treatment start per RECIST 1.1 based on local investigator assessment

Detailed description

SAEs (serious adverse events) and AEs (adverse events) according to NCI CTCAE v5.0, by grade and their relationship to milademetan and/or fulvestrant., PFS (Progression-free survival), ORR (objective response rate), DoR (duration of response), OS (overall survival), The measure of interest is the mean difference in the change from baseline to different specific visits (each disease radiological assessment, disease progression and/or treatment discontinuation) in total/subscale scores of the 5 Dimension 5 Level (EQ-5D-5L) scale., Quantitative and qualitative analyses of ctDNA collected at baseline, during therapy and at tumor progression; GATA3 and MDM2 IHC on tumor tissue, Digital pathology analyses on tumor tissue.

Related papers

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Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMilademetan

DRUGFulvestrant 250 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of patients who have achieved either a confirmed complete or partial response, or stable disease for at least 24 weeks after treatment start per RECIST 1.1 based on local investigator assessment	—

Secondary

Measure	Time frame
SAEs (serious adverse events) and AEs (adverse events) according to NCI CTCAE v5.0, by grade and their relationship to milademetan and/or fulvestrant., PFS (Progression-free survival), ORR (objective response rate), DoR (duration of response), OS (overall survival), The measure of interest is the mean difference in the change from baseline to different specific visits (each disease radiological assessment, disease progression and/or treatment discontinuation) in total/subscale scores of the 5 Dimension 5 Level (EQ-5D-5L) scale., Quantitative and qualitative analyses of ctDNA collected at baseline, during therapy and at tumor progression; GATA3 and MDM2 IHC on tumor tissue, Digital pathology analyses on tumor tissue.	—

Measure

Time frame

SAEs (serious adverse events) and AEs (adverse events) according to NCI CTCAE v5.0, by grade and their relationship to milademetan and/or fulvestrant., PFS (Progression-free survival), ORR (objective response rate), DoR (duration of response), OS (overall survival), The measure of interest is the mean difference in the change from baseline to different specific visits (each disease radiological assessment, disease progression and/or treatment discontinuation) in total/subscale scores of the 5 Dimension 5 Level (EQ-5D-5L) scale., Quantitative and qualitative analyses of ctDNA collected at baseline, during therapy and at tumor progression; GATA3 and MDM2 IHC on tumor tissue, Digital pathology analyses on tumor tissue.

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Countries

France

Outcome results

None listed