HER2-PET: Predicting T-DXd Efficacy and HER2 Heterogeneity
ConditionBreast Cancer Metastatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFudan University
About this trial
The study will be conducted as an open-label, single-center, Phase II clinical study, with a planned enrollment of 86 patients with locally advanced or metastatic HER2-positive and HER2-low breast cancer who are intended to receive at least two cycles of T-DXd monotherapy. All patients receiving T-DXd treatment must meet current clinical indications. After screening and enrollment, participants will undergo FDG-PET scans and free-of-charge HER2-PET scans prior to T-DXd treatment, with tissue biopsies performed as needed. Participants will receive single-agent T-DXd treatment until disease progression, with additional tissue biopsies performed as needed.This study will integrate and analyze patients' baseline clinical characteristics, treatment efficacy, and prognostic information, along with HER2 expression levels and HER2 expression heterogeneity as assessed by HER2-PET, to evaluate the feasibility of guiding T-DXd treatment in patients with advanced breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hemoglobin ≥ 9.0 g/dL;
Absolute neutrophil count (ANC) ≥ 1,500/mm³;
Platelet count ≥ 100,000/mm³;
At baseline, total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) in the absence of liver metastases, or < 3.0 × ULN in the presence of Gilbert's syndrome (unconjugated hyperbilirubinemia) or documented liver metastases;
Disqualifiers
Uncontrolled concurrent diseases, including but not limited to: persistent or active infections, uncontrolled or significant cardiovascular disease, severe chronic gastrointestinal disease with diarrhea, or psychiatric/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or impair the patient's ability to provide written informed consent.
History of myocardial infarction or symptomatic congestive heart failure (CHF) (NYHA Class II to IV) within 6 months prior to randomization. Patients with troponin levels above the Upper Limit of Normal (ULN) (as defined by the manufacturer) at screening without any symptoms related to myocardial infarction should undergo cardiac consultation prior to randomization to rule out myocardial infarction;
Uncontrolled hypertension;
Uncontrolled and/or clinically significant arrhythmias.
Trial population
advanced breast cancer patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PET
Other interventionHER2-PET/CT and FDG-PET/CT
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Advanced Breast Cancer1 intervention
Trial outcomes
Primary outcomes
1
negative predictive value (NPV)
Negative Predictive Value of HER2 Expression as Assessed by HER2-PET for Objective Response.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov