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

Condition studied

advanced/metastatic HER2-positive breast carcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

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)

Endpoint detail

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”