NCT07046455

Trop-2 Targeted PET Probes in Advanced TNBC

Translational Research on the Construction of Trop-2 Targeted PET Probes and Their Application in Advanced Triple-Negative Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

According to inclusion and exclusion criteria, 20 eligible subjects with triple-negative breast cancer (TNBC) scheduled to receive sacituzumab govitecan were screened. Relevant examination results within 2 weeks before enrollment, including blood and urine routine tests, blood biochemistry, electrocardiogram, serum pregnancy test (for females only), imaging examinations, vital signs, and physical examinations, were collected as baseline assessments to determine whether subjects met enrollment requirements. After enrollment, subjects underwent 89Zr-DFO-hSR7 and 18F-FDG examinations at three time points: before sacituzumab govitecan treatment, after 2 cycles of treatment, and at disease progression. (Subjects first underwent 18F-FDG examination, followed by 89Zr-DFO-hSR7 examination within 1 week.) Within 2 years (with a 1-month window) after completing baseline examinations, investigators will conduct 3-5 follow-ups (at 1 month, 6 months, 1 year, 1.5 years, and 2 years post-examination) via medical record system review or telephone interviews to collect laboratory test results, pathological findings, comprehensive diagnostic results from other imaging modalities, and compare the efficacy of TROP-2 ADC therapy with the results of 89Zr-DFO-hSR7 and 18F-FDG examinations. This is an exploratory study, initially planned to enroll 20 cases. After obtaining preliminary sample data, further analysis will be conducted to calculate the required sample size. The radiation dose of the drug is approximately 0.02-0.03 mCi/kg. The quality standards for the formulation will be established in accordance with the Chinese Pharmacopoeia (2020 Edition).

Detailed description

1. Primary Objectives To evaluate the correlation between 89Zr-DFO-hSR7 uptake in tumor lesions and TROP2 expression in breast cancer tissues. To compare the diagnostic efficacy of 89Zr-DFO-hSR7 and 18F-FDG in breast cancer lesions, including sensitivity, specificity, and accuracy. To investigate the validity of 89Zr-DFO-hSR7 in assessing the efficacy of sacituzumab govitecan therapy for breast cancer. 2. Secondary Objectives To clarify the in vivo distribution and metabolism of 89Zr-DFO-hSR7. To monitor resistance to sacituzumab govitecan therapy and explore potential resistance mechanisms. 3. Primary Endpoints The relationship between changes in SUV values on 89Zr-DFO-hSR7 PET imaging before and after sacituzumab govitecan treatment and therapeutic response in breast cancer patients. Pathological biopsy results corresponding to suspiciously positive lesions identified by 89Zr-DFO-hSR7 PET imaging. 4. Secondary Endpoints The tumor-to-background ratio (TBR) of standardized uptake values (SUVs) of 89Zr-DFO-hSR7 in target lesions or suspected tumor lesions versus normal tissues within each time window. To evaluate the in vivo biodistribution of 89Zr-DFO-hSR7 and its temporal changes. To assess/compare the clinical utility of the probe in breast cancer patients.

Conditions

• TNBC - Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan (SG)	After enrollment, before subjects receive TROP-2 ADC treatment, after 2 cycles of treatment, and at the time of progression, in these three phases, subjects will undergo 89Zr-DFO-hSR7 and 18F-FDG examinations once respectively (subjects will first undergo the 18F-FDG examination, and then the 89Zr-DFO-hSR7 examination within 1 week).

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-03-01
• Completion: 2027-09-01
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: China