A Study of T-DXd in AI-Assessed HER2-Ultralow Metastatic Breast Cancer
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShuangyue Liu
About this trial
This is a prospective, multicenter, single-arm study designed to verify the efficacy and safety of trastuzumab deruxtecan (T-DXd) in subjects with hormone receptor-positive (HR+) unresectable and/or metastatic breast cancer who are identified as HER2-ultralow by artificial intelligence (AI)-assisted re-scoring after being manually scored as HER2-null. Eligible subjects will have progressed on at least one and up to two prior lines of endocrine therapy in the metastatic setting. Subjects are permitted to have received no more than one prior chemotherapy in the metastatic setting; however, chemotherapy must not have been the most recent treatment regimen at disease progression. Approximately 30 subjects will be enrolled at about 15 sites in China. The primary endpoint is objective response rate (ORR) by investigator assessment per RECIST 1.1.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of ICF prior to any study-specific qualification procedures.
Adults ≥ 18 years of age at the time the ICF is signed.
Must have an adequate tumor tissue sample available for assessment of HER2 status obtained most recently at the time of metastatic disease or later. If a suitable archival sample is not available, a fresh biopsy sample may be used to determine eligibility.
Is unresectable and/or metastatic.
Disqualifiers
Subjects with contraindications to T-DXd per the local prescribing information and T-DXd IB cannot be enrolled to the study.
Previous treatment with anti-HER2 therapy.
Prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor.
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Trial design
Design model
Single group
Treatments tested in this trial
Trastuzumab Deruxtecan (T-DXd, ENHERTU®)
Drug5.4 mg/kg IV infusion every 3 weeks (Q3W)
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Trastuzumab Deruxtecan (T-DXd) Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by Investigator.
Time frame
From first dose to progression/death, assessed every 6 weeks for 24 weeks, then every 12 weeks, up to approximate 36 months following subject enrolment.Secondary outcomes
1
PFS
PFS is defined as the time from first dose of study treatment until progression per RECIST 1.1 as assessed by Investigator, or death due to any cause in the absence of progression regardless of whether the subject withdraws from study treatment or received another anticancer therapy prior to progression.
Time frame
From first dose to progression/death, assessed every 6 weeks for 24 weeks, then every 12 weeks, up to approximate 36 months following subject enrolment.2
DCR
DCR is defined as the percentage of subjects who have a BOR of CR/PR/SD.
Time frame
From first dose to progression/death, assessed every 6 weeks for 24 weeks, then every 12 weeks, up to approximate 36 months following subject enrolment .3
DoR
DoR is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression as assessed by the Investigator per RECIST 1.1 or death in the absence of disease progression.
Time frame
From confirmed response to progression/death, assessed every 6 weeks for 24 weeks, then every 12 weeks, up to approximate 36 months following subject enrolment .Other outcomes
1
Safety Objective
TEAEs, SAEs, AESIs, AEs leading to discontinuation of study treatment, AEs leading to study treatment dose interruptions, AEs leading to study treatment dose reduction and AEs leading to withdrawal from study.
Time frame
From ICF signing through 40 days post-last dose or until subsequent therapy, up to approximate 36 months following subject enrolment .2
OS
OS is defined as the time from the date of the first dose of study treatment until death due to any cause regardless of whether the subject withdraws from study intervention or receives another anticancer therapy.
Time frame
From first dose to death, assessed every 3 months during LTFU, up to approximate 36 months following subject enrolment .3
Al-assisted Re-scoring Data
1\. The proportion of screened subjects re-scored as HER2-ultralow by AI assistance among the subjects identified as HER2-null by manual scoring. 2. The absolute number and percentage of membrane-stained tumor cells as determined by AI analysis.
Time frame
Tissue screening period prior to screening.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shuangyue Liu
Lead sponsor
West China Hospital
Sponsor institution
Source ClinicalTrials.gov
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