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Breast Cancer Metastatic / PET · Observational Study
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry entry for an ongoing observational study evaluating whether HER2-PET imaging can predict T-DXd efficacy and map HER2 heterogeneity in advanced breast cancer. No efficacy or safety data are reported in this registry record; the study is still recruiting and designed to assess feasibility and the negative predictive value of the imaging modality.
Observational. Breast Cancer Metastatic; Female; age from 18 Years. Intervention: Advanced Breast Cancer. n = 100. 1 site: China.
This is a registry entry for an ongoing observational study evaluating whether HER2-PET imaging can predict T-DXd efficacy and map HER2 heterogeneity in advanced breast cancer. No efficacy or safety data are reported in this registry record; the study is still recruiting and designed to assess feasibility and the negative predictive value of the imaging modality.
No efficacy, safety, or outcome data are reported in this registry record; study is actively recruiting. Primary outcome is negative predictive value only; other efficacy or safety measures are not stated.
This study is in recruitment and has not yet generated results. Once complete, it may inform whether HER2-PET can guide T-DXd treatment selection in advanced breast cancer, but readers should await published outcomes before clinical application.
This is a registry record for an ongoing observational study with planned enrollment; no results are reported, making it a feasibility and imaging validation study in early phases.
As stated by the source record.
Quoted from the source exactly as published.
This study is in recruitment and has not yet generated results. Once complete, it may inform whether HER2-PET can guide T-DXd treatment selection in advanced breast cancer, but readers should await published outcomes before clinical application.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07586215). This is a study registration, not published results. Lead sponsor: Fudan University. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Breast Cancer Metastatic. Interventions: OTHER: PET. Primary outcome measures: negative predictive value (NPV) , through study completion, an average of 1 year. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.