Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in Advanced Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The predictive value of series 68Ga-MY6349 PET/CT in patients with breast cancer who received Trop2-ADC therapy
Study Overview
Brief Summary
To evaluate whether serial 68Ga-MY6349 PET/CT imaging can serve as a noninvasive biomarker to predict the therapeutic efficacy of Trop2-targeted antibody-drug conjugate (Trop2-ADC) therapy in breast cancer patients.
Detailed Description
Patients diagnosed with metastatic breast cancer will undergo 68Ga-MY6349 PET/CT imaging at baseline and after two cycles of Trop2-ADC therapy. Tumor uptake will be quantified using both maximum standardized uptake value (SUVmax) and mean SUV (SUVmean). Imaging changes will be correlated with treatment response to assess the utility of 68Ga-MY6349 PET/CT as a predictive biomarker.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The predictive value of series 68Ga-MY6349 PET/CT in patients with breast cancer who received Trop2-ADC therapy
Time Frame: 2024.11-2026.6
For 68Ga-MY6349 PET/CT parameter, the maximum standard uptake value (SUVmax) is measured by defining a region of interest (ROI) around the primary tumor. SUVmax values obtained at baseline and after two cycles of Trop2-ADC therapy were collected and analyzed in relation to treatment response.
Secondary Outcomes
- Correlation Between PET Parameters and Survival(2024.11-2026.12)