Breast CancerNCT06715020
Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging
A study testing 18F-FDG and [68Ga]Ga-TTP in people with Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The objective of the study is to construct a noninvasive approach 68Ga-TTP PET/CT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 18F-FDG and [68Ga]Ga-TTP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to Dec 2026
- 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
- Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);
- Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 /L, PLT ≥ 100×109/L, Hb≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;
- Patients with confirmed or suspected breast cancer;
- Expected survival ≥12 weeks;
- Good follow-up compliance;
- Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;
- Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.
Who cannot join
- Severe abnormal liver and kidney function;
- Pregnant, pregnant and lactating women;
- Can not lie flat for half an hour;
- Unable to obtain informed consent;
- Suffering from claustrophobia or other mental illness;
- People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;
- Other conditions deemed unsuitable for participation in the trial by the investigator.
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
Peking University Cancer Hospital & Institute
Beijing, 100143
Zhi Yang, 010-88196196, pekyz@163.com
About this study
The objective of the study is to construct a noninvasive approach 68Ga-TTP PET/CT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.
- Conditions
- Breast Cancer
- Being tested
- 18F-FDG, [68Ga]Ga-TTP
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
[18F]FDG is administered intravenously as the comparator PET radiotracer. In the diagnostic validation cohort, participants undergo one [18F]FDG PET examination within 1 week of the [68Ga]Ga-TTP scan, with no treatment between scans. In the ADC response assessment cohort, participants undergo [18F]FDG PET imaging at the same three time points as [68Ga]Ga-TTP: before ADC therapy, after 2 cycles(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.1-0.15 mCi/kg.
[68Ga]Ga-TTPDrug
[68Ga]Ga-TTP is a TROP2-targeted PET radiotracer administered intravenously for PET imaging. In the diagnostic validation cohort, participants undergo one [68Ga]Ga-TTP PET examination within 1 week of the comparator [18F]FDG scan. In the ADC response assessment cohort, participants undergo [68Ga]Ga-TTP PET imaging before ADC therapy, after 2 cycles of treatment(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.05-0.1 mCi/kg.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Validation Cohort | Experimental | Patients with newly diagnosed or suspected breast cancer will undergo one [68Ga]Ga-TTP scan and one [18F]FDG scan within 1 week, in randomized order, with no anticancer treatment administered between the two imaging examinations. This cohort is used to evaluate tumor targeting, compare diagnostic performance with [18F]FDG, and correlate imaging findings with pathology and TROP2 expression. Receives: Drug: 18F-FDG; Drug: [68Ga]Ga-TTP |
| ADC Response Assessment Cohort | Experimental | Patients with breast cancer who are planned to receive TROP2-directed ADC therapy will undergo paired [68Ga]Ga-TTP and [18F]FDG imaging at three time points: before treatment, after 2 cycles of ADC therapy(each cycle is 21 days), and at disease progression. This cohort is used to assess longitudinal imaging changes and their relationship with treatment response. Receives: Drug: 18F-FDG; Drug: [68Ga]Ga-TTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of [68Ga]Ga-TTP PET compared with [18F]FDG PET for breast cancer lesions
To compare the diagnostic performance of [68Ga]Ga-TTP PET and [18F]FDG PET for breast cancer lesions, including sensitivity, specificity, accuracy, false-positive rate, and false-negative rate, using pathology and/or integrated follow-up assessment as reference standard.
Measured: Within 1 week after paired baseline imaging and within 2 months of follow-up/reference standard assessment
Change in [68Ga]Ga-TTP uptake in relation to ADC treatment response
To evaluate the association between changes in tumor uptake on [68Ga]Ga-TTP PET (e.g., SUV or SUVmax) before treatment, after 2 cycles of TROP2-directed ADC therapy(each cycle is 21 days), and at disease progression, and clinical treatment response in patients with breast cancer receiving ADC therapy.assessed up to 24 months.
Measured: Baseline before ADC therapy, at the end of Cycle 2 of ADC therapy (each cycle is 21 days), and from the start of ADC therapy until first documented disease progression, assessed up to 24 months.
Secondary outcomes (3)
Correlation between [68Ga]Ga-TTP uptake and TROP2 expression in tumor tissue
To evaluate the correlation between standardized uptake values of [68Ga]Ga-TTP PET in target or suspected tumor lesions and TROP2 expression level in corresponding pathological tissue samples.
Measured: At baseline PET/CT imaging and from 4 weeks before to 8 weeks after baseline imaging for pathological tissue assessment.
Biodistribution and temporal distribution pattern of [68Ga]Ga-TTP in patients
To assess the in vivo biodistribution, organ uptake, and temporal distribution characteristics of [68Ga]Ga-TTP in patients with breast cancer at different imaging time windows.
Measured: From injection to 40 minutes post-injection for dynamic PET imaging; at 50-60 minutes post-injection for routine static PET/CT imaging; and at 2 hours post-injection and 3 hours post-injection for delayed PET/CT imaging in the dynamic-imaging subgroup.
Pathological results of lesions suspected to be positive on [68Ga]Ga-TTP PET
To assess the pathological findings of lesions suspected to be positive on [68Ga]Ga-TTP PET imaging, including concordance with biopsy or surgical pathology when available.
Measured: Within 2 months after imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start10 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Yunnan Cancer Hospital
- Responsible party
- Principal investigator, Hua Zhu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715020
- Sponsor's protocol ID
- 2024KT140
- Status last verified
- May 2026
- First submitted
- 26 Nov 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging
- ClinicalTrials.gov ID
- NCT06715020
- Acronym / sponsor ID
- 2024KT140
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Yunnan Cancer Hospital
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Dec 2024 (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.
The objective of the study is to construct a noninvasive approach 68Ga-TTP PET/CT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Validation Cohort | Experimental | Drug: 18F-FDG, Drug: [68Ga]Ga-TTPPatients with newly diagnosed or suspected breast cancer will undergo one [68Ga]Ga-TTP scan and one [18F]FDG scan within 1 week, in randomized order, with no anticancer treatment administered between the two imaging examinations. This cohort is used to evaluate tumor targeting, compare diagnostic performance with [18F]FDG, and correlate imaging findings with pathology and TROP2 expression. |
| ADC Response Assessment Cohort | Experimental | Drug: 18F-FDG, Drug: [68Ga]Ga-TTPPatients with breast cancer who are planned to receive TROP2-directed ADC therapy will undergo paired [68Ga]Ga-TTP and [18F]FDG imaging at three time points: before treatment, after 2 cycles of ADC therapy(each cycle is 21 days), and at disease progression. This cohort is used to assess longitudinal imaging changes and their relationship with treatment response. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);
- Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 /L, PLT ≥ 100×109/L, Hb≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;
- Patients with confirmed or suspected breast cancer;
- Expected survival ≥12 weeks;
- Good follow-up compliance;
Key exclusion criteria (7 listed)
- Severe abnormal liver and kidney function;
- Pregnant, pregnant and lactating women;
- Can not lie flat for half an hour;
- Unable to obtain informed consent;
- Suffering from claustrophobia or other mental illness;
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 |
|---|---|---|
| 18F-FDG[18F]FDG is administered intravenously as the comparator PET radiotracer. In the diagnostic validation cohort, participants undergo one [18F]FDG PET examination within 1 week of the [68Ga]Ga-TTP scan, with no treatment between scans. In the ADC response assessment cohort, participants undergo [18F]FDG PET imaging at the same three time points as [68Ga]Ga-TTP: before ADC therapy, after 2 cycles(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.1-0.15 mCi/kg. | Drug | ADC Response Assessment Cohort, Diagnostic Validation Cohort |
| [68Ga]Ga-TTP[68Ga]Ga-TTP is a TROP2-targeted PET radiotracer administered intravenously for PET imaging. In the diagnostic validation cohort, participants undergo one [68Ga]Ga-TTP PET examination within 1 week of the comparator [18F]FDG scan. In the ADC response assessment cohort, participants undergo [68Ga]Ga-TTP PET imaging before ADC therapy, after 2 cycles of treatment(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.05-0.1 mCi/kg. | Drug | ADC Response Assessment Cohort, Diagnostic Validation Cohort |
Primary outcome
Diagnostic performance of [68Ga]Ga-TTP PET compared with [18F]FDG PET for breast cancer lesions
Time frame: Within 1 week after paired baseline imaging and within 2 months of follow-up/reference standard assessment
To compare the diagnostic performance of [68Ga]Ga-TTP PET and [18F]FDG PET for breast cancer lesions, including sensitivity, specificity, accuracy, false-positive rate, and false-negative rate, using pathology and/or integrated follow-up assessment as reference standard.
Change in [68Ga]Ga-TTP uptake in relation to ADC treatment response
Time frame: Baseline before ADC therapy, at the end of Cycle 2 of ADC therapy (each cycle is 21 days), and from the start of ADC therapy until first documented disease progression, assessed up to 24 months.
To evaluate the association between changes in tumor uptake on [68Ga]Ga-TTP PET (e.g., SUV or SUVmax) before treatment, after 2 cycles of TROP2-directed ADC therapy(each cycle is 21 days), and at disease progression, and clinical treatment response in patients with breast cancer receiving ADC therapy.assessed up to 24 months.
3 secondary outcomes
Correlation between [68Ga]Ga-TTP uptake and TROP2 expression in tumor tissue
Time frame: At baseline PET/CT imaging and from 4 weeks before to 8 weeks after baseline imaging for pathological tissue assessment.
Biodistribution and temporal distribution pattern of [68Ga]Ga-TTP in patients
Time frame: From injection to 40 minutes post-injection for dynamic PET imaging; at 50-60 minutes post-injection for routine static PET/CT imaging; and at 2 hours post-injection and 3 hours post-injection for delayed PET/CT imaging in the dynamic-imaging subgroup.
Pathological results of lesions suspected to be positive on [68Ga]Ga-TTP PET
Time frame: Within 2 months after imaging
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 11 Aug 2026.
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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 18F-FDG and [68Ga]Ga-TTP in people with 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 7 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 11 Aug 2026. 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 Zhi Yang (010-88196196, pekyz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of [68Ga]Ga-TTP PET compared with [18F]FDG PET for breast cancer lesions (time frame: Within 1 week after paired baseline imaging and within 2 months of follow-up/reference standard assessment). 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 11 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.