Trastuzumab Deruxtecan (T-DXd): Tailoring Treatment and Companion Diagnostics (CDx) by Liquid Biopsy. DIAMOND STUDY

Conditions

metastatic HER2-positive breast cancer patients

Brief summary

Concordance in progression between RECIST v1.1 and CTDNA at 1 year after the start of treatment. CTDNA will be categorised as either presence or no presence of circulating genomic alterations associated with pharmacological resistance and susceptibility to T-DXd.Genomic alterations will be considered as new appearance and/or increasing of existing alterations

Detailed description

Listing of circulating alterations during treatment and at progression: particularly those actionable at OncoKB level 3A/B or lower, particularly when ctDNA-only, Liquid biopsy Lead Time Progression Free survival (PFS-LB) compared to medical imaging, Lead Time is defined as the time to progression by RECIST1.1 criteria (PFS-R) - (minus, subtraction) the time to progression by circulating tumor DNA, e.g. PFS-ctDNA. Days of Lead Time = days PFS-R - days PFS-ctDNA, PFS assessed between two groups of patients in relation with HER2-2D: HER2 status lower vs higher detected by LB, Safety endpoint: Toxicity will be graded according to NCICTCAE vers. 5.0, Exploratory endpoint: Presence of tissue genomic alterations (from primary or last available tumor tissue) associated with pharmacological resistance and susceptibility to T-DXd to be compared with those found on liquid biopsy

Related papers

No related papers found yet.

Interventions

DRUGTRASTUZUMAB DERUXTECAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Concordance in progression between RECIST v1.1 and CTDNA at 1 year after the start of treatment. CTDNA will be categorised as either presence or no presence of circulating genomic alterations associated with pharmacological resistance and susceptibility to T-DXd.Genomic alterations will be considered as new appearance and/or increasing of existing alterations	—

Secondary

Measure	Time frame
Listing of circulating alterations during treatment and at progression: particularly those actionable at OncoKB level 3A/B or lower, particularly when ctDNA-only, Liquid biopsy Lead Time Progression Free survival (PFS-LB) compared to medical imaging, Lead Time is defined as the time to progression by RECIST1.1 criteria (PFS-R) - (minus, subtraction) the time to progression by circulating tumor DNA, e.g. PFS-ctDNA. Days of Lead Time = days PFS-R - days PFS-ctDNA, PFS assessed between two groups of patients in relation with HER2-2D: HER2 status lower vs higher detected by LB, Safety endpoint: Toxicity will be graded according to NCICTCAE vers. 5.0, Exploratory endpoint: Presence of tissue genomic alterations (from primary or last available tumor tissue) associated with pharmacological resistance and susceptibility to T-DXd to be compared with those found on liquid biopsy	—

Measure

Time frame

Listing of circulating alterations during treatment and at progression: particularly those actionable at OncoKB level 3A/B or lower, particularly when ctDNA-only, Liquid biopsy Lead Time Progression Free survival (PFS-LB) compared to medical imaging, Lead Time is defined as the time to progression by RECIST1.1 criteria (PFS-R) - (minus, subtraction) the time to progression by circulating tumor DNA, e.g. PFS-ctDNA. Days of Lead Time = days PFS-R - days PFS-ctDNA, PFS assessed between two groups of patients in relation with HER2-2D: HER2 status lower vs higher detected by LB, Safety endpoint: Toxicity will be graded according to NCICTCAE vers. 5.0, Exploratory endpoint: Presence of tissue genomic alterations (from primary or last available tumor tissue) associated with pharmacological resistance and susceptibility to T-DXd to be compared with those found on liquid biopsy

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Countries

Italy

Outcome results

None listed