Using 68Ga‑MY6349 PET/CT to track response to Trop2‑targeted therapy in breast cancer
Official title: Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in Advanced Breast Cancer
Run by The First Affiliated Hospital of Xiamen University · NCT07046689 · Data updated 2026-11-12
This study tries to see if repeated 68Ga‑MY6349 PET/CT scans can predict how well Trop2‑targeted antibody‑drug conjugate (Trop2‑ADC) treatment will work for adults with metastatic breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 15, 2025 |
| Trial ID | NCT07046689 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (aged 18 or older) with histologically or cytologically confirmed metastatic breast cancer who are planned for Trop2‑ADC therapy, have at least one measurable lesion by RECIST 1.1, and have ECOG performance status 0–1 are ideal candidates.
✕Probably not a fit
Patients with significant liver or kidney dysfunction, an estimated life expectancy under three months, or who cannot undergo PET/CT scans are unlikely to benefit from this imaging protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with metastatic breast cancer who are starting Trop2‑ADC therapy will have 68Ga‑MY6349 PET/CT scans at baseline and after two treatment cycles. Tumor uptake will be measured using SUVmax and SUVmean on the PET/CT images. Those imaging changes will be compared with clinical and radiographic treatment response using RECIST 1.1 criteria. The aim is to determine whether early changes in tracer uptake can serve as a noninvasive predictive biomarker of therapeutic benefit.
Why it matters
Potential benefit: If successful, this imaging approach could let doctors identify early whether Trop2‑ADC is working, potentially avoiding ineffective therapy and guiding treatment decisions.
How similar studies have gone: PET tracers used to predict response to other targeted ADCs (for example, HER2‑directed imaging) have shown promising results, but Trop2‑specific PET imaging is relatively new and less validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients (aged 18 years or order) * histologically or cytologically confirmed metastatic breast cancer previously treated with systemic therapy, supported by imaging (e.g., MRI, CT), tumor markers, or pathology reports * presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 * willingness to undergo serial 68Ga-MY6349 PET/CT scans before and during Trop2-ADC therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Ability to provide written informed consent and, where applicable, assent in accordance with the requirements of the Clinical Research Ethics Committee Exclusion Criteria: * Evidence of significantly impaired hepatic or renal function * Estimated life expectancy of less than 3 months
Where it's running
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China Recruiting
Study contacts
- Study coordinator: Liang Zhao, phd
- Email: wzhaoliang01@163.com
- Phone: 86 18818350620
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.