NCT07471776RecruitingPhase 2
Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
This study aims to evaluate whether \^68Ga-TROP2 PET/CT, combined with \^18F-FDG PET/CT, can predict the efficacy of anti-TROP2 antibody-drug conjugates in patients with advanced HER2-negative breast cancer. Baseline and dynamic imaging parameters will be used to develop prediction models (primary endpoint: AUC), and their associations with clinical outcomes and tumor TROP2 status will be explored.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 10 Mar 2026
- Start date
- 11 Mar 2026
- Primary completion date
- 11 Mar 2028
- Lead sponsor
- Fudan University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07471776
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 11 Mar 2026 to the primary completion date, 11 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior exposure to an anti-TROP2 ADC.
Other illness
- Patients with known contraindications to PET/CT or known allergy to \^18F-FDG or the \^68Ga-TROP2 tracer (or their components).
- Patients diagnosed with secondary primary tumors (other active malignancies), as determined by the investigator.
Other
- Patients with incomplete medical records or inability to complete the required imaging assessments.
- Patients who are pregnant or breastfeeding.
Who the study is looking for
- Patients diagnosed with advanced/metastatic HER2-negative breast cancer with confirmed metastatic disease, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
- Patients who are planned to receive anti-TROP2 antibody-drug conjugate (ADC) therapy (e.g., sacituzumab govitecan or datopotamab deruxtecan) as part of routine clinical care.
- Patients who will undergo protocol-defined \^68Ga-TROP2 PET/CT and \^18F-FDG PET/CT during the study (baseline imaging, with repeat imaging per protocol if applicable).
- Adult patients (≥18 years) who are able to provide informed consent and comply with study procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.