Metastatic Breast Cancer ( HER2 Negative)Phase 2NCT07471776
Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
A Phase 2 study testing Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan, 68Ga-TROP2 PET/CT Imaging and 18F-FDG PET Imaging in people with Metastatic Breast Cancer ( HER2 Negative), run by Fudan University at 2 sites in China.
Trial summary
This study aims to evaluate whether ^68Ga-TROP2 PET/CT, combined with ^18F-FDG PET/CT, can predict the efficacy of anti-TROP2 antibody-drug conjugates in patients with advanced HER2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer ( HER2 Negative)
- What is being tested?
- Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan, 68Ga-TROP2 PET/CT Imaging and 18F-FDG PET Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- 11 Mar 2026to 11 Mar 2029
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with advanced/metastatic HER2-negative breast cancer with confirmed metastatic disease, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
- Patients who are planned to receive anti-TROP2 antibody-drug conjugate (ADC) therapy (e.g., sacituzumab govitecan or datopotamab deruxtecan) as part of routine clinical care.
- Patients who will undergo protocol-defined ^68Ga-TROP2 PET/CT and ^18F-FDG PET/CT during the study (baseline imaging, with repeat imaging per protocol if applicable).
- Adult patients (≥18 years) who are able to provide informed consent and comply with study procedures.
Who cannot join
- Patients with incomplete medical records or inability to complete the required imaging assessments.
- Patients with prior exposure to an anti-TROP2 ADC.
- Patients with known contraindications to PET/CT or known allergy to ^18F-FDG or the ^68Ga-TROP2 tracer (or their components).
- Patients who are pregnant or breastfeeding.
- Patients diagnosed with secondary primary tumors (other active malignancies), as determined by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Biyun wang, 021-64175590, wangbiyun0107@hotmail.com
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Biyun Wang, 18017312387, wangbiyun0107@hotmail.com
About this study
This study aims to evaluate whether ^68Ga-TROP2 PET/CT, combined with ^18F-FDG PET/CT, can predict the efficacy of anti-TROP2 antibody-drug conjugates in patients with advanced HER2-negative breast cancer. Baseline and dynamic imaging parameters will be used to develop prediction models (primary endpoint: AUC), and their associations with clinical outcomes and tumor TROP2 status will be explored.
- Being tested
- Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan, 68Ga-TROP2 PET/CT Imaging, 18F-FDG PET Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecanDrug
TROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity.
68Ga-TROP2 PET/CT ImagingDiagnostic test
Whole-body PET imaging using 68Ga-labeled TROP2-targeting tracer to assess in vivo TROP2 expression prior to TROP2 ADC treatment initiation.
18F-FDG PET ImagingDiagnostic test
Standard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity.
| Study group | Role | What they receive |
|---|---|---|
| TROP2 ADC | Other | Not described Receives: Drug: Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan; Diagnostic Test: 68Ga-TROP2 PET/CT Imaging; Diagnostic Test: 18F-FDG PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of the Imaging-Based Prediction Model
Measured: Baseline to first response assessment (after 2 cycles of therapy)
Secondary outcomes (3)
Predictive Value of Baseline 68Ga-TROP2 PET/CT (± 18F-FDG PET/CT) Parameters
Measured: Baseline to first response assessment (after 2 cycles of therapy).
Correlation Between 68Ga-TROP2 PET Uptake and Tissue TROP2 Status
Measured: At baseline
Comparative Performance: 68Ga-TROP2 PET/CT vs 18F-FDG PET/CT
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start11 Mar 2026
- Primary completion11 Mar 2028 (estimated)
- Study completion11 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer ( HER2 Negative)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471776
- Sponsor's protocol ID
- YOUNGBC-34
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07471776
- Acronym / sponsor ID
- YOUNGBC-34
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 11 Mar 2028 (estimated)
- Study completion
- 11 Mar 2029 (estimated)
- First posted
- 13 Mar 2026 (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.
This study aims to evaluate whether ^68Ga-TROP2 PET/CT, combined with ^18F-FDG PET/CT, can predict the efficacy of anti-TROP2 antibody-drug conjugates in patients with advanced HER2-negative breast cancer. Baseline and dynamic imaging parameters will be used to develop prediction models (primary endpoint: AUC), and their associations with clinical outcomes and tumor TROP2 status will be explored.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TROP2 ADC | Other | Drug: Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan, Diagnostic Test: 68Ga-TROP2 PET/CT Imaging, Diagnostic Test: 18F-FDG PET Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with advanced/metastatic HER2-negative breast cancer with confirmed metastatic disease, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
- Patients who are planned to receive anti-TROP2 antibody-drug conjugate (ADC) therapy (e.g., sacituzumab govitecan or datopotamab deruxtecan) as part of routine clinical care.
- Patients who will undergo protocol-defined ^68Ga-TROP2 PET/CT and ^18F-FDG PET/CT during the study (baseline imaging, with repeat imaging per protocol if applicable).
- Adult patients (≥18 years) who are able to provide informed consent and comply with study procedures.
Key exclusion criteria (5 listed)
- Patients with incomplete medical records or inability to complete the required imaging assessments.
- Patients with prior exposure to an anti-TROP2 ADC.
- Patients with known contraindications to PET/CT or known allergy to ^18F-FDG or the ^68Ga-TROP2 tracer (or their components).
- Patients who are pregnant or breastfeeding.
- Patients diagnosed with secondary primary tumors (other active malignancies), as determined by the investigator.
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、Datopotamab deruxtecan、Sacituzumab tirumotecanTROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity. | Drug | TROP2 ADC |
| 68Ga-TROP2 PET/CT ImagingWhole-body PET imaging using 68Ga-labeled TROP2-targeting tracer to assess in vivo TROP2 expression prior to TROP2 ADC treatment initiation. | Diagnostic test | TROP2 ADC |
| 18F-FDG PET ImagingStandard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity. | Diagnostic test | TROP2 ADC |
Primary outcome
Area Under the Curve (AUC) of the Imaging-Based Prediction Model
Time frame: Baseline to first response assessment (after 2 cycles of therapy)
3 secondary outcomes
Predictive Value of Baseline 68Ga-TROP2 PET/CT (± 18F-FDG PET/CT) Parameters
Time frame: Baseline to first response assessment (after 2 cycles of therapy).
Correlation Between 68Ga-TROP2 PET Uptake and Tissue TROP2 Status
Time frame: At baseline
Comparative Performance: 68Ga-TROP2 PET/CT vs 18F-FDG PET/CT
Time frame: At baseline
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 13 Mar 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan, 68Ga-TROP2 PET/CT Imaging and 18F-FDG PET Imaging in people with Metastatic Breast Cancer ( HER2 Negative), run by Fudan University at 2 sites 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 4 inclusion and 5 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Biyun Wang (021-64175590, wangbiyun0107@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) of the Imaging-Based Prediction Model (time frame: Baseline to first response assessment (after 2 cycles of therapy)). 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 13 Mar 2026.