RecruitingNot ApplicableNCT07046455

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


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

20 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special PET scan (a type of imaging) with a new probe that targets a protein called Trop-2 to better evaluate treatment response in people with advanced triple-negative breast cancer (TNBC) who are receiving a type of targeted therapy called a Trop-2 antibody-drug conjugate (ADC). **You may be eligible if...** - You are 18–75 years old with confirmed advanced triple-negative breast cancer - Your doctor has recommended Trop-2 ADC as your current treatment - You have at least one measurable lesion on imaging - You are able to lie flat for at least 30 minutes for the scan - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You have severe liver or kidney problems - You are pregnant, trying to get pregnant, or breastfeeding - You cannot lie flat for the scan - You have known allergies to the study drug - You have claustrophobia or severe mental illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab 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).


Locations(1)

Beijing Cancer Hospital

Beijing, China

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NCT07046455


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