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RecruitingNCT07046455Updated Jul 1, 2025

Trop-2 Targeted PET Probes in Advanced TNBC

An interventional study of Sacituzumab Govitecan (SG) in TNBC - Triple-Negative Breast Cancer, sponsored by Peking University Cancer Hospital & Institute. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Peking University Cancer Hospital & Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2025, registered Jun 2025).
  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the detailed description

  1. Primary Objectives To evaluate the correlation between 89Zr-DFO-hSR7 uptake in tumor lesions and TROP2 expression in breast cancer tissues.

    To compare the diagnostic efficacy of 89Zr-DFO-hSR7 and 18F-FDG in breast cancer lesions, including sensitivity, specificity, and accuracy.

    To investigate the validity of 89Zr-DFO-hSR7 in assessing the efficacy of sacituzumab govitecan therapy for breast cancer.

  2. Secondary Objectives To clarify the in vivo distribution and metabolism of 89Zr-DFO-hSR7. To monitor resistance to sacituzumab govitecan therapy and explore potential resistance mechanisms.

  3. Primary Endpoints The relationship between changes in SUV values on 89Zr-DFO-hSR7 PET imaging before and after sacituzumab govitecan treatment and therapeutic response in breast cancer patients.

    Pathological biopsy results corresponding to suspiciously positive lesions identified by 89Zr-DFO-hSR7 PET imaging.

  4. Secondary Endpoints The tumor-to-background ratio (TBR) of standardized uptake values (SUVs) of 89Zr-DFO-hSR7 in target lesions or suspected tumor lesions versus normal tissues within each time window.

To evaluate the in vivo biodistribution of 89Zr-DFO-hSR7 and its temporal changes.

To assess/compare the clinical utility of the probe in breast cancer patients.

02

Conditions studied

  • TNBC - Triple-Negative Breast Cancer

Keywords

  • Trop-2
  • PET probe
  • triple-negative breast cancer (TNBC)
03

In context

Triple Negative Breast Neoplasms

1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 442 are open to participants now.

This study's planned enrollment of 20 is below the median of 61 across 981 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    PET-CT Probe+ Trop-2 ADC

    Drug: Sacituzumab Govitecan (SG)

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).

06

What researchers measure

Primary outcomes

  1. changes in SUV values

    SUV values of each tumor lesion in 89Zr-DFO-hSR7 PET/CT and 18F-FDG PET/CT imaging before and after sacituzumab govitecan treatment

    Time frame: Enrollment up for approximately 36 months.

  2. Pathological biopsy results

    Pathological biopsy results corresponding to suspiciously positive lesions identified by 89Zr-DFO-hSR7 PET imaging.

    Time frame: Enrollment up for approximately 36 months.

Secondary outcomes

  1. The tumor-to-background ratio (TBR)

    The tumor-to-background ratio (TBR) of standardized uptake values (SUVs) of 89Zr-DFO-hSR7 in target lesions or suspected tumor lesions versus normal tissues within each time window.

    Time frame: Enrollment up for approximately 36 months.

07

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, 100142, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07046455
Lead sponsor
Peking University Cancer Hospital & Institute
Responsible party
songguohong (Chief Physician, Deputy Director of the Department, Medical Oncology of Breast Cancer, Peking University Cancer Hospital & Institute) — Principal investigator
First posted
Jul 1, 2025
Start date
Mar 1, 2025
Primary completion
Mar 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Jul 1, 2025

Study contacts

Guohong Song, Doctor of Medicine (M.D.)
Contact
songguohong918@hotmail.com
0086-88121122-2066

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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