Trop-2 Targeted PET Probes in Advanced TNBC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat, mężczyzna lub kobieta, w dobrym stanie ogólnym (ECOG ≥ 2)
- •Prawidłowe wyniki badań krwi: liczba białych ciałek krwi ≥ 3,0×10⁹/L, płytki krwi ≥ 80×10⁹/L, hemoglobina ≥ 80 g/L
- •Prawidłowe wyniki wątroby i nerek: bilirubina ≤ 1,5× norma, enzymy wątroby ≤ 2,5× norma, kreatynina ≤ 1,5× norma
- •Potwierdzona zaawansowana rak piersi potrójnie ujemny (badanie histopatologiczne i obrazowe)
- •Przewidywany czas przeżycia co najmniej 12 tygodni
- •Lekarz uzna, że proponowane leczenie jest dla pacjenta odpowiednie
- •Co najmniej jeden mierzalny guz widoczny w badaniu (według standardu RECIST 1.1)
- •Kobieta w wieku rozrodczym musi mieć negatywny test ciąży; osoby płodne muszą stosować skuteczną antykoncepcję przez badanie i 3 miesiące po nim
✗ Disqualifies
- •Poważne zaburzenia czynności wątroby i nerek
- •Kobieta w okresie przygotowywania się do ciąży, w ciąży lub karmiąca piersią
- •Niemożność leżenia płasko przez 30 minut
- •Niemożność wyrażenia świadomej zgody
- •Klaustrofobia lub inne choroby psychiczne
- •Znana alergia na lek testowy lub jego składniki
- •Inne sytuacje, które badacz uzna za nieodpowiednie do udziału w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 1, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Beijing Cancer Hospital
Beijing, China
Trial contact
Guohong Song, Doctor of Medicine (M.D.)
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.