Breast CancerNCT07046689
PET/CT for Trop2 ADC Response Evaluation Cancers
An observational study of Breast Cancer and Trop2, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To evaluate whether serial 68Ga-MY6349 PET/CT imaging can serve as a noninvasive biomarker to predict the therapeutic efficacy of Trop2-targeted antibody-drug conjugate (Trop2-ADC) therapy in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Trop2, PET/CT
- What is being tested?
- 68Ga-MY6349 PET/CT
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2026
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients with previously treated metastatic breast cancer (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report).
Who may be able to join
- adult patients (aged 18 years or order)
- histologically or cytologically confirmed metastatic breast cancer previously treated with systemic therapy, supported by imaging (e.g., MRI, CT), tumor markers, or pathology reports
- presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
- willingness to undergo serial 68Ga-MY6349 PET/CT scans before and during Trop2-ADC therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Ability to provide written informed consent and, where applicable, assent in accordance with the requirements of the Clinical Research Ethics Committee
Who cannot join
- Evidence of significantly impaired hepatic or renal function
- Estimated life expectancy of less than 3 months
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
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Liang Zhao, 86 0592-213-7366, wzhaoliang01@163.com
About this study
Official title: Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in Advanced Breast Cancer
To evaluate whether serial 68Ga-MY6349 PET/CT imaging can serve as a noninvasive biomarker to predict the therapeutic efficacy of Trop2-targeted antibody-drug conjugate (Trop2-ADC) therapy in breast cancer patients.
Read the detailed description
Patients diagnosed with metastatic breast cancer will undergo 68Ga-MY6349 PET/CT imaging at baseline and after two cycles of Trop2-ADC therapy. Tumor uptake will be quantified using both maximum standardized uptake value (SUVmax) and mean SUV (SUVmean). Imaging changes will be correlated with treatment response to assess the utility of 68Ga-MY6349 PET/CT as a predictive biomarker.
- Conditions
- Breast Cancer, Trop2, PET/CT
- Being tested
- 68Ga-MY6349 PET/CT
- Keywords
- Breast cancer, Trop2, PET/CT, Trop2-ADC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-MY6349 PET/CTDiagnostic test
Each participant will receive an intravenous injection of 68Ga-MY6349 and undergo PET/CT imaging at baseline and following two cycles of Trop2-ADC therapy.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-MY6349 PET/CT | Each participant will receive an intravenous injection of 68Ga-MY6349 and undergo PET/CT imaging at baseline and following two cycles of Trop2-ADC therapy. Receives: Diagnostic Test: 68Ga-MY6349 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive value of series 68Ga-MY6349 PET/CT in patients with breast cancer who received Trop2-ADC therapy
For 68Ga-MY6349 PET/CT parameter, the maximum standard uptake value (SUVmax) is measured by defining a region of interest (ROI) around the primary tumor. SUVmax values obtained at baseline and after two cycles of Trop2-ADC therapy were collected and analyzed in relation to treatment response.
Measured: 2024.11-2026.6
Secondary outcomes (1)
Correlation Between PET Parameters and Survival
Progression-free survival (PFS) amd overall survival (OS) will be monitored and analyzed in relation to imaging parameters obtained from serial 68Ga-MY6349 PET/CT scans.
Measured: 2024.11-2026.12
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 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046689
- Sponsor's protocol ID
- XMYY-2025KY102
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07046689
- Acronym / sponsor ID
- XMYY-2025KY102
- Conditions
- Breast Cancer, Trop2, PET/CT
- Keywords
- Breast cancer, Trop2, PET/CT, Trop2-ADC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (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.
To evaluate whether serial 68Ga-MY6349 PET/CT imaging can serve as a noninvasive biomarker to predict the therapeutic efficacy of Trop2-targeted antibody-drug conjugate (Trop2-ADC) therapy in breast cancer patients.
Detailed description
Patients diagnosed with metastatic breast cancer will undergo 68Ga-MY6349 PET/CT imaging at baseline and after two cycles of Trop2-ADC therapy. Tumor uptake will be quantified using both maximum standardized uptake value (SUVmax) and mean SUV (SUVmean). Imaging changes will be correlated with treatment response to assess the utility of 68Ga-MY6349 PET/CT as a predictive biomarker.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-MY6349 PET/CT | – | Diagnostic Test: 68Ga-MY6349 PET/CTEach participant will receive an intravenous injection of 68Ga-MY6349 and undergo PET/CT imaging at baseline and following two cycles of Trop2-ADC therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients with previously treated metastatic breast cancer (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report).
Key inclusion criteria (6 listed)
- adult patients (aged 18 years or order)
- histologically or cytologically confirmed metastatic breast cancer previously treated with systemic therapy, supported by imaging (e.g., MRI, CT), tumor markers, or pathology reports
- presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
- willingness to undergo serial 68Ga-MY6349 PET/CT scans before and during Trop2-ADC therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Key exclusion criteria (2 listed)
- Evidence of significantly impaired hepatic or renal function
- Estimated life expectancy of less than 3 months
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 |
|---|---|---|
| 68Ga-MY6349 PET/CTEach participant will receive an intravenous injection of 68Ga-MY6349 and undergo PET/CT imaging at baseline and following two cycles of Trop2-ADC therapy. | Diagnostic test | 68Ga-MY6349 PET/CT |
Primary outcome
The predictive value of series 68Ga-MY6349 PET/CT in patients with breast cancer who received Trop2-ADC therapy
Time frame: 2024.11-2026.6
For 68Ga-MY6349 PET/CT parameter, the maximum standard uptake value (SUVmax) is measured by defining a region of interest (ROI) around the primary tumor. SUVmax values obtained at baseline and after two cycles of Trop2-ADC therapy were collected and analyzed in relation to treatment response.
1 secondary outcome
Correlation Between PET Parameters and Survival
Time frame: 2024.11-2026.12
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 15 Jul 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Breast Cancer and Trop2, run by The First Affiliated Hospital of Xiamen University 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 6 inclusion and 2 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 15 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 Liang Zhao, phd (86 18818350620, wzhaoliang01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive value of series 68Ga-MY6349 PET/CT in patients with breast cancer who received Trop2-ADC therapy (time frame: 2024.11-2026.6). 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 15 Jul 2025.