NCT07471776

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
32mo left

Started Mar 2026

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Mar 2029

First Submitted

Initial submission to the registry

March 10, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

March 11, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2029

Last Updated

March 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

March 10, 2026

Last Update Submit

March 10, 2026

Conditions

Metastatic Breast Cancer ( HER2 Negative)

Outcome Measures

Primary Outcomes (1)

  • Area Under the Curve (AUC) of the Imaging-Based Prediction Model

    Baseline to first response assessment (after 2 cycles of therapy)

Secondary Outcomes (3)

  • 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

Other Outcomes (1)

  • Immune Markers in Tissue/Blood and Associations With Imaging and Efficacy

    Baseline through first response assessment (after 2 cycles of therapy) and at disease progression.

Study Arms (1)

TROP2 ADC

OTHER
Drug: Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecanDiagnostic Test: 68Ga-TROP2 PET/CT ImagingDiagnostic Test: 18F-FDG PET Imaging

Interventions

Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecanDRUG

TROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity.

TROP2 ADC
68Ga-TROP2 PET/CT ImagingDIAGNOSTIC_TEST

Whole-body PET imaging using 68Ga-labeled TROP2-targeting tracer to assess in vivo TROP2 expression prior to TROP2 ADC treatment initiation.

TROP2 ADC
18F-FDG PET ImagingDIAGNOSTIC_TEST

Standard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity.

TROP2 ADC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Biyun Wang

CONTACT

021-64175590wangbiyun0107@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

March 11, 2026

Primary Completion (Estimated)

March 11, 2028

Study Completion (Estimated)

March 11, 2029

Last Updated

March 13, 2026

Record last verified: 2026-02

Locations

CN(2)