TROP2‑PET and FDG‑PET to predict response to anti‑TROP2 antibody‑drug therapy in advanced HER2‑negative breast cancer

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

See if combining a TROP2 PET scan with an FDG PET scan can predict who with advanced HER2‑negative breast cancer will respond to anti‑TROP2 antibody‑drug treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: sacituzumab, datopotamab
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07471776 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study will perform baseline and dynamic 68Ga‑TROP2 PET/CT and 18F‑FDG PET/CT scans in patients with metastatic HER2‑negative breast cancer who are starting anti‑TROP2 ADC therapy. Imaging parameters will be used to build prediction models with area under the curve (AUC) as the primary endpoint. The study will also explore how the imaging markers relate to clinical outcomes and tumor TROP2 status. Patients will receive standard‑of‑care anti‑TROP2 ADCs such as sacituzumab govitecan or datopotamab deruxtecan while imaging data are collected.

Who should consider this trial

Good fit: Adults (≥18) with confirmed advanced or metastatic HER2‑negative breast cancer who are about to start anti‑TROP2 ADC therapy and can undergo PET/CT imaging are ideal candidates.

Not a fit: Patients previously treated with an anti‑TROP2 ADC, those unable to complete PET/CT or with contraindications or pregnancy, and patients with HER2‑positive disease are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the scans could help doctors identify patients most likely to benefit from anti‑TROP2 ADCs and avoid ineffective treatments for others.

How similar studies have performed: Anti‑TROP2 ADCs like sacituzumab govitecan and datopotamab deruxtecan have shown clinical benefit in other metastatic breast cancer trials, but using 68Ga‑TROP2 PET to predict response is a novel approach with limited prior data.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Biyun Wang

Conditions Metastatic Breast Cancer