Trop‑2–targeted PET imaging for advanced triple‑negative breast cancer
Translational Research on the Construction of Trop-2 Targeted PET Probes and Their Application in Advanced Triple-Negative Breast Cancer
This project will test whether a Trop‑2–targeted PET scan (89Zr‑DFO‑hSR7) can find Trop‑2–positive tumors and track response to sacituzumab govitecan in people with advanced triple‑negative breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | sacituzumab, radiation |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07046455 on ClinicalTrials.gov |
What this trial studies
About 20 patients with advanced triple‑negative breast cancer who are scheduled to receive sacituzumab govitecan will be enrolled and have baseline labs, imaging, and clinical assessments. Participants will undergo both 18F‑FDG and 89Zr‑DFO‑hSR7 PET/CT scans before treatment, after two cycles of therapy, and at disease progression, with biopsies of suspicious lesions when feasible. The trial will compare diagnostic performance and uptake metrics of 89Zr‑DFO‑hSR7 versus 18F‑FDG, correlate tracer uptake with tumor TROP2 expression, and monitor changes in uptake with treatment. Investigators will also describe the in vivo biodistribution and metabolism of 89Zr‑DFO‑hSR7 and follow patients for up to two years with scheduled follow‑ups.
Who should consider this trial
Good fit: Adults (18–75) with advanced triple‑negative breast cancer who are scheduled to receive sacituzumab govitecan, have at least one measurable lesion by RECIST 1.1, and meet required laboratory and organ‑function criteria are the intended participants.
Not a fit: Patients whose tumors lack TROP2 expression, who cannot undergo PET/CT imaging, who are pregnant, or who are not candidates for sacituzumab govitecan are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this imaging approach could help identify tumors that express TROP2 and provide an early, noninvasive way to monitor whether sacituzumab govitecan is working.
How similar studies have performed: Sacituzumab govitecan is an established TROP2‑targeting therapy, but clinical use of Trop‑2–targeted PET probes like 89Zr‑DFO‑hSR7 in patients is relatively novel with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 - 75 years, male or female, with an ECOG score ≥ 2. 2. Blood routine, liver and kidney functions meet the following standards: * Blood routine: Total white blood cell count (WBC) ≥ 3.0×10⁹/L or neutrophil count (Neu) ≥ 1.5×10⁹/L, platelet count (PLT) ≥ 80×10⁹/L, hemoglobin (Hb) ≥ 80 g/L. * Liver and kidney functions: Total bilirubin (T - Bil) ≤ 1.5×ULN (upper limit of normal value), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN or ≤ 5×ULN (in case of liver metastasis), serum creatinine (SCr) ≤ 1.5×ULN. 3. Subjects with advanced triple - negative breast cancer previously diagnosed by histopathological diagnosis and imaging evaluation. 4. Expected survival time ≥ 12 weeks. 5. Clinicians assess that TROP - 2 ADC is an appropriate treatment plan for the subject at present. 6. There is at least one measurable target lesion in accordance with the RECIST 1.1 standard. 7. Subjects for whom clinicians recommend PET/CT examination for breast tumor diagnosis and staging. 8. Women of childbearing age (18 - 60 years old) must undergo a pregnancy test within 7 days before the start of the examination and the result is negative; Male and female subjects with fertility must agree to use effective contraceptive measures to ensure no pregnancy during the study period and within 3 months after the examination. 9. The subject can fully understand and voluntarily participate in this experiment, sign the informed consent form, and have good follow - up compliance. Exclusion Criteria: 1. Severe abnormalities in liver and kidney functions; 2. Women who are in the pre - pregnancy period, pregnant or lactating; 3. Those who cannot lie flat for half an hour; 4. Those who cannot provide informed consent; 5. Those suffering from claustrophobia or other mental illnesses; 6. Those known to be allergic to the investigational drugs or their excipients used in the study treatment; 7. Other situations that the researchers consider make it inappropriate to participate in the trial.
Where this trial is running
Beijing
- Beijing Cancer Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Guohong Song, Doctor of Medicine (M.D.)
- Email: songguohong918@hotmail.com
- Phone: 0086-88121122-2066
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.