Breast CancerNCT07316439
Comparison Between ER Loss and Triple-Negative Breast Cancer Guided by 18F-FES PET/CT in Metastatic Breast Cancer
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study aimed to compare survival outcomes and clinical characteristics between ER loss and metastatic triple-negative breast cancer (mTNBC) patients, exploring the prognostic implications of dynamic ER changes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 197 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 5 Jun 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: MBC patients with ER-positive primary tumor who detected negative ER expression in metastatic disease using 18F-FES PET/CT at Fudan University Shanghai Cancer Center. Contemporaneous patients with metastatic TNBC at initial diagnosis at Fudan University Shanghai Cancer Center.
Who may be able to join
- Patients diagnosed with breast cancer (according to International Classification of Diseases 10th Revision) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
- MBC patients who underwent 18F-FES PET/CT at the Fudan University Shanghai Cancer Center between 2017 and 2023
- Patients diagnosed with primary ER-positive tumor and who were yet to receive any systemic therapy during the advanced stage
- Contemporaneous patients with metastatic TNBC at initial diagnosis
Who cannot join
- Patients with incomplete medical records and those diagnosed with secondary primary tumors
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Clinical Outcomes of ER-Positive to Negative Conversion Versus Triple-Negative Breast Cancer (TNBC): Evidence From a 18F-fluoroestradiol Positron Emission Tomography/Computed Tomography (18F-FES PET/CT) Guided Propensity-Score-Matched Study
This study aimed to compare survival outcomes and clinical characteristics between ER loss and metastatic triple-negative breast cancer (mTNBC) patients, exploring the prognostic implications of dynamic ER changes.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ER negative conversion group | 82 patients with functional ER loss detected by FES-PET at metastatic sites before first-line treatment | |
| mTNBC | A total of 115 contemporaneous patients with metastatic TNBC at initial diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Measured: 6 weeks
Secondary outcomes (2)
Overall Response Rate
Measured: 6 weeks
Disease Control Rate
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start31 Dec 2024
- Primary completion5 Jun 2025
- Study completion5 Jun 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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
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
- NCT07316439
- Sponsor's protocol ID
- YOUNGBC-36
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of ER-Positive to Negative Conversion Versus Triple-Negative Breast Cancer (TNBC): Evidence From a 18F-fluoroestradiol Positron Emission Tomography/Computed Tomography (18F-FES PET/CT) Guided Propensity-Score-Matched Study
- ClinicalTrials.gov ID
- NCT07316439
- Acronym / sponsor ID
- YOUNGBC-36
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 5 Jan 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 aimed to compare survival outcomes and clinical characteristics between ER loss and metastatic triple-negative breast cancer (mTNBC) patients, exploring the prognostic implications of dynamic ER changes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ER negative conversion group | – | –82 patients with functional ER loss detected by FES-PET at metastatic sites before first-line treatment |
| mTNBC | – | –A total of 115 contemporaneous patients with metastatic TNBC at initial diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MBC patients with ER-positive primary tumor who detected negative ER expression in metastatic disease using 18F-FES PET/CT at Fudan University Shanghai Cancer Center. Contemporaneous patients with metastatic TNBC at initial diagnosis at Fudan University Shanghai Cancer Center.
Key inclusion criteria (4 listed)
- Patients diagnosed with breast cancer (according to International Classification of Diseases 10th Revision) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
- MBC patients who underwent 18F-FES PET/CT at the Fudan University Shanghai Cancer Center between 2017 and 2023
- Patients diagnosed with primary ER-positive tumor and who were yet to receive any systemic therapy during the advanced stage
- Contemporaneous patients with metastatic TNBC at initial diagnosis
Key exclusion criteria (1 listed)
- Patients with incomplete medical records and those diagnosed with secondary primary tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival
Time frame: 6 weeks
2 secondary outcomes
Overall Response Rate
Time frame: 6 weeks
Disease Control Rate
Time frame: 6 weeks
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 5 Jan 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Fudan 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 6 weeks). 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 5 Jan 2026.