Using 68Ga‑MY6349 PET/CT to track response to Trop2‑targeted therapy in breast cancer
Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in Advanced Breast Cancer
The First Affiliated Hospital of Xiamen University · NCT07046689
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The First Affiliated Hospital of Xiamen University (other) |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT07046689 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Xiamen, Fujian
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Trop2, PET/CT, Breast cancer, Trop2-ADC