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RECRUITING

NCT07046455

Trop-2 Targeted PET Probes in Advanced TNBC

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-03-01

Completion Date

2027-09-01

Last Updated

2025-07-01

Healthy Volunteers

Conditions

TNBC - Triple-Negative Breast Cancer

Interventions

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).

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.

Locations (1)

Beijing Cancer Hospital

Beijing, China