TNBC - Triple-Negative Breast CancerNCT07046455
Trop-2 Targeted PET Probes in Advanced TNBC
A study testing Sacituzumab Govitecan (SG) in people with TNBC - Triple-Negative Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Sacituzumab Govitecan (SG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
- Those suffering from claustrophobia or other mental illnesses;
- Those known to be allergic to the investigational drugs or their excipients used in the study treatment;
- Other situations that the researchers consider make it inappropriate to participate in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
Guohong Song, Doctor of Medicine (M.D.), 0086-88121122-2066, songguohong918@hotmail.com
About this study
Official title: Translational Research on the Construction of Trop-2 Targeted PET Probes and Their Application in Advanced Triple-Negative Breast Cancer
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
- 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.
- 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.
- 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.
- 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.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- Sacituzumab Govitecan (SG)
- Keywords
- Trop-2, PET probe, triple-negative breast cancer (TNBC)
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Govitecan (SG)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| PET-CT Probe+ Trop-2 ADC | Experimental | Not described Receives: Drug: Sacituzumab Govitecan (SG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Enrollment up for approximately 36 months.
Pathological biopsy results
Pathological biopsy results corresponding to suspiciously positive lesions identified by 89Zr-DFO-hSR7 PET imaging.
Measured: 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.
Measured: Enrollment up for approximately 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, songguohong, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046455
- Sponsor's protocol ID
- Y-Gilead2024-PT-0099
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Research on the Construction of Trop-2 Targeted PET Probes and Their Application in Advanced Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07046455
- Acronym / sponsor ID
- Y-Gilead2024-PT-0099
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Keywords
- Trop-2, PET probe, triple-negative breast cancer (TNBC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-CT Probe+ Trop-2 ADC | Experimental | Drug: Sacituzumab Govitecan (SG) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 - 75 years, male or female, with an ECOG score ≥ 2.
- Blood routine, liver and kidney functions meet the following standards:
- 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.
Key exclusion criteria (7 listed)
- 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;
- Those suffering from claustrophobia or other mental illnesses;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | PET-CT Probe+ Trop-2 ADC |
Primary outcome
changes in SUV values
Time frame: Enrollment up for approximately 36 months.
SUV values of each tumor lesion in 89Zr-DFO-hSR7 PET/CT and 18F-FDG PET/CT imaging before and after sacituzumab govitecan treatment
Pathological biopsy results
Time frame: Enrollment up for approximately 36 months.
Pathological biopsy results corresponding to suspiciously positive lesions identified by 89Zr-DFO-hSR7 PET imaging.
1 secondary outcome
The tumor-to-background ratio (TBR)
Time frame: Enrollment up for approximately 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacituzumab Govitecan (SG) in people with TNBC - Triple-Negative Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guohong Song, Doctor of Medicine (M.D.) (0086-88121122-2066, songguohong918@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in SUV values (time frame: Enrollment up for approximately 36 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.