Actively Recruiting
Trop-2 Targeted PET Probes in Advanced TNBC
Led by Peking University Cancer Hospital & Institute · Updated on 2025-07-01
20
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Trop-2 Targeted PET Probes in Advanced TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female, with an ECOG score of 2 or higher
- Blood tests showing white blood cell count ≥ 3.0 x10⁹/L or neutrophil count ≥ 1.5 x10⁹/L, platelet count ≥ 80 x10⁹/L, hemoglobin ≥ 80 g/L
- Liver and kidney function within specified limits: total bilirubin ≤ 1.5 times upper limit of normal, ALT and AST ≤ 2.5 times upper limit (or ≤ 5 times if liver metastasis), serum creatinine ≤ 1.5 times upper limit
- Diagnosed with advanced triple-negative breast cancer by histopathology and imaging
- Expected survival time of at least 12 weeks
- Clinician assessment that TROP-2 ADC therapy is appropriate
- At least one measurable target lesion per RECIST 1.1 criteria
- Recommended by clinicians for PET/CT breast tumor diagnosis and staging
- Women of childbearing age (18-60) have a negative pregnancy test within 7 days before examination
- Male and female participants with fertility agree to effective contraception during the study and for 3 months after
- Able to understand and voluntarily participate, sign informed consent, and comply with follow-up
You will not qualify if you...
- Severe liver or kidney function abnormalities
- Women who are pre-pregnancy, pregnant, or breastfeeding
- Unable to lie flat for half an hour
- Unable to provide informed consent
- Claustrophobia or other mental illnesses
- Known allergies to investigational drugs or their ingredients
- Other conditions deemed inappropriate by the researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
Research Team
G
Guohong Song, Doctor of Medicine (M.D.)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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