HER2 molecular imaging with 89Zr-trastuzumab PET/CT as a predictive biomarker for antibody-drug conjugate sequencing in patients with advanced HER2-positive breast cancer

Conditions

advanced/metastatic HER2-positive breast carcinoma

Brief summary

Characterization of genomic alterations and HER2 expression., Time to treatment failure (TTF): defined as the time from T-DM1 start to discontinuation for any reason, including disease progression (clinical or image-based on 18FDG-PET/CT), treatment toxicity or death in participants with a “positive” HER2-PET/CT (per metabolic response)

Detailed description

Overall response to T-DM1 assessed by metabolic response (subjects with a “positive” HER2-PET/CT)., OS defined from the start of treatment to the date of death from any cause (subjects with a “positive” HER2-PET/CT)., DoR defined as the time from the date of first documentation of response (CR or PR) to disease progression or death, in participants who achieve complete or partial response assessed by metabolic response (subjects with a “positive” HER2-PET/CT).., DCR defined as absence of disease progression (subjects with a “positive” HER2-PET/CT)., Incidence, nature, and severity of adverse events, including but not limited to drug induced liver injury, described in the section 9.1.2.2 “Recording and reporting of AEs by the investigators” and in the section 9.2.1 “Adverse Events of Special Interest – Definitions”

Related papers

No related papers found yet.

Interventions

DRUG89Zr-Trastuzumab_IJB

DRUGHerceptin 150 mg powder for concentrate for solution for infusion

DRUGTRASTUZUMAB EMTANSINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Characterization of genomic alterations and HER2 expression., Time to treatment failure (TTF): defined as the time from T-DM1 start to discontinuation for any reason, including disease progression (clinical or image-based on 18FDG-PET/CT), treatment toxicity or death in participants with a “positive” HER2-PET/CT (per metabolic response)	—

Secondary

Measure	Time frame
Overall response to T-DM1 assessed by metabolic response (subjects with a “positive” HER2-PET/CT)., OS defined from the start of treatment to the date of death from any cause (subjects with a “positive” HER2-PET/CT)., DoR defined as the time from the date of first documentation of response (CR or PR) to disease progression or death, in participants who achieve complete or partial response assessed by metabolic response (subjects with a “positive” HER2-PET/CT).., DCR defined as absence of disease progression (subjects with a “positive” HER2-PET/CT)., Incidence, nature, and severity of adverse events, including but not limited to drug induced liver injury, described in the section 9.1.2.2 “Recording and reporting of AEs by the investigators” and in the section 9.2.1 “Adverse Events of Special Interest – Definitions”	—

Measure

Time frame

Overall response to T-DM1 assessed by metabolic response (subjects with a “positive” HER2-PET/CT)., OS defined from the start of treatment to the date of death from any cause (subjects with a “positive” HER2-PET/CT)., DoR defined as the time from the date of first documentation of response (CR or PR) to disease progression or death, in participants who achieve complete or partial response assessed by metabolic response (subjects with a “positive” HER2-PET/CT).., DCR defined as absence of disease progression (subjects with a “positive” HER2-PET/CT)., Incidence, nature, and severity of adverse events, including but not limited to drug induced liver injury, described in the section 9.1.2.2 “Recording and reporting of AEs by the investigators” and in the section 9.2.1 “Adverse Events of Special Interest – Definitions”

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Countries

Belgium

Outcome results

None listed