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Nectin-4 PET to Predict Response to Nectin-4-Targeted Therapy in Advanced Breast Cancer

NCT07708922 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-07-16

No results posted yet for this study

Summary

This is a prospective, single-arm, exploratory clinical trial that plans to enroll 40 patients with locally advanced or metastatic breast cancer who are expected to participate in a therapeutic clinical trial of a Nectin-4-targeted agent at our center and receive at least two treatment cycles. All participants must meet the eligibility criteria of the therapeutic clinical trial in which they intend to participate and provide separate written informed consent for this study. The Nectin-4-targeted agents used in the two clinical trials currently underway at our center are provided to participants free of charge.

All participants must undergo an \^18F-FDG PET/CT scan and a complimentary \^68Ga-FZ-NR-1 PET/CT scan (Nectin-4 PET) within 28 days before initiating treatment with a Nectin-4-targeted agent. After completing the baseline assessments, participants will begin treatment in accordance with the protocol of the therapeutic clinical trial of the Nectin-4-targeted agent in which they are enrolled and will be followed according to the requirements of the corresponding protocol until disease progression, unacceptable toxicity, or withdrawal from the study.

Participants will be encouraged to undergo an additional complimentary Nectin-4 PET/CT scan after completion of the first treatment cycle and within 7 days before administration of the second treatment cycle to assess early changes in target expression during treatment.

Peripheral blood samples will be collected at baseline, before the first dose of Cycle 3, and at disease progression. Participants will also be encouraged to undergo needle biopsy of a metastatic lesion at baseline and at disease progression to explore potential mechanisms of resistance and other relevant biomarkers.

All PET/CT images will be independently reviewed by two physicians from the Department of Nuclear Medicine at our center who have extensive experience in diagnostic imaging.

Conditions

  • Breast Cancer Metastatic

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-07-30
Completion
2029-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708922 on ClinicalTrials.gov