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Clinical Trial NCT07471776 for Metastatic Breast Cancer ( HER2 Negative) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer Phase 2 45

Recruiting
Clinical Trial NCT07471776 is designed to study Diagnostic for Metastatic Breast Cancer ( HER2 Negative). It is a Phase 2 interventional study that is recruiting, having started on 11 March 2026, with plans to enroll 45 participants. Led by Fudan University, it is expected to complete by 11 March 2029. The latest data from ClinicalTrials.gov was last updated on 13 March 2026.
Brief Summary
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.
Official Title

Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer

Conditions
Metastatic Breast Cancer ( HER2 Negative)
Other Study IDs
  • YOUNGBC-34
NCT ID Number
NCT07471776
Start Date (Actual)
2026-03-11
Last Update Posted
2026-03-13
Completion Date (Estimated)
2029-03-11
Enrollment (Estimated)
45
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherTROP2 ADC
Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan
TROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity.
68Ga-TROP2 PET/CT Imaging
Whole-body PET imaging using 68Ga-labeled TROP2-targeting tracer to assess in vivo TROP2 expression prior to TROP2 ADC treatment initiation.
18F-FDG PET Imaging
Standard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Area Under the Curve (AUC) of the Imaging-Based Prediction Model
Baseline to first response assessment (after 2 cycles of therapy)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Predictive Value of Baseline 68Ga-TROP2 PET/CT (± 18F-FDG PET/CT) Parameters
Baseline to first response assessment (after 2 cycles of therapy).
Correlation Between 68Ga-TROP2 PET Uptake and Tissue TROP2 Status
At baseline
Comparative Performance: 68Ga-TROP2 PET/CT vs 18F-FDG PET/CT
At baseline
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • Patients with incomplete medical records or inability to complete the required imaging assessments.
  • Patients with prior exposure to an anti-TROP2 ADC.
  • Patients with known contraindications to PET/CT or known allergy to ^18F-FDG or the ^68Ga-TROP2 tracer (or their components).
  • Patients who are pregnant or breastfeeding.
  • Patients diagnosed with secondary primary tumors (other active malignancies), as determined by the investigator.
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Study Responsible Party
Biyun Wang, MD, Principal Investigator, Professor, Fudan University
Study Central Contact
Contact: Biyun Wang, 021-64175590, [email protected]
2 Study Locations in 1 Countries

Shanghai Municipality

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, 200032, China
Biyun wang, Contact, 021-64175590, [email protected]
Recruiting
Fudan University Shanghai Cancer Center, Shanghai, 200032, China
Biyun Wang, Contact, 18017312387, [email protected]
Not yet recruiting