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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: wangbiyun0107@hotmail.com
• Phone: 021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.