NCT07046455Recruiting

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

Source: ClinicalTrials.gov · Last updated 1 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry): Recruiting
Study type: Interventional
Enrollment: 20 (estimated)
First submitted: 13 Jun 2025
Start date: 1 Mar 2025
Primary completion date: 1 Mar 2027
Lead sponsor: Peking University Cancer Hospital & Institute
Diseases: Triple-negative breast cancer
NCT number: NCT07046455

What you commit to

Study type: Interventional
Planned participants: 20
From 1 Mar 2025 to the primary completion date, 1 Mar 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Those known to be allergic to the investigational drugs or their excipients used in the study treatment;

Other illness

Those suffering from claustrophobia or other mental illnesses;

Other

Severe abnormalities in liver and kidney functions;
Women who are in the pre - pregnancy period, pregnant or lactating;
Those who cannot lie flat for half an hour;
Those who cannot provide informed consent;
Other situations that the researchers consider make it inappropriate to participate in the trial.

Who the study is looking for

Aged 18 - 75 years, male or female, with an ECOG score ≥ 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.
Subjects with advanced triple - negative breast cancer previously diagnosed by histopathological diagnosis and imaging evaluation.
Expected survival time ≥ 12 weeks.
Clinicians assess that TROP - 2 ADC is an appropriate treatment plan for the subject at present.
There is at least one measurable target lesion in accordance with the RECIST 1.1 standard.
Subjects for whom clinicians recommend PET/CT examination for breast tumor diagnosis and staging.
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.
The subject can fully understand and voluntarily participate in this experiment, sign the informed consent form, and have good follow - up compliance.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Beijing Cancer Hospital Coordinator of this site? Confirm its status	Beijing	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.