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HER2-PET: Predicting T-DXd Efficacy and HER2 Heterogeneity

NCT07586215 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-14

No results posted yet for this study

Summary

The study will be conducted as an open-label, single-center, Phase II clinical study, with a planned enrollment of 70 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.

Conditions

  • Breast Cancer Metastatic

Interventions

OTHER

PET

HER2-PET/CT and FDG-PET/CT

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2026-11-11
Completion
2026-12-11

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07586215 on ClinicalTrials.gov