Breast CancerNCT06655545
18F-fluoroestradiol (18F-FES) PET/CT Guided First-line Treatment for HR+/HER2- Metastatic Breast Cancer Patients
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
A single-center, real world study to evaluate the role of FES-PET in guiding the first-line treatment of HR+/HER2- MBC patients. 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
- 473 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2023to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between January 2020 to February 2024.
Who may be able to join
- age >= 18 years old;
- Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between January 2020 to February 2024;
- Received CDK4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle;
- Complete medical history was available.
Who cannot join
- 1. Medical history was incomplete.
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: A Single-center, Real-world Study Exploring the Guidance of FES-PET for First-line Treatment of HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer Patients
A single-center, real world study to evaluate the role of FES-PET in guiding the first-line treatment of HR+/HER2- MBC patients.
- Conditions
- Breast Cancer
- Keywords
- chemotherapy, CDK4/6 inhibitors, 18F-fluoroestradiol (18F-FES) PET/CT, HR positive, HER2 negative
- 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 |
|---|---|---|
| FES-guided CDK4/6 inhibitor plus endocrine therapy cohort | The group guided with FES-PET using a CDK4/6 inhibitor plus ET. | |
| FES-guided chemotherapy cohort | The group guided with FES-PET using chemotherapy. | |
| Non-FES-guided CDK4/6 inhibitor plus endocrine therapy cohort | The group examined without FES-PET using a CDK4/6 inhibitor plus ET. | |
| Non-FES-guided chemotherapy cohort | The group examined without FES-PET using chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: 6 weeks
Secondary outcomes (1)
OS
overall-survival
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 posted23 Oct 2024
- Study start15 Jul 2023
- Primary completion15 Oct 2024
- Study completion1 Feb 2025
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
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
- Investigators
- Biyun Wang, professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655545
- Sponsor's protocol ID
- YOUNGBC-31
- Status last verified
- Dec 2024
- First submitted
- 22 Oct 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Real-world Study Exploring the Guidance of FES-PET for First-line Treatment of HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06655545
- Acronym / sponsor ID
- YOUNGBC-31
- Conditions
- Breast Cancer
- Keywords
- chemotherapy, CDK4/6 inhibitors, 18F-fluoroestradiol (18F-FES) PET/CT, HR positive, HER2 negative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 23 Oct 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.
A single-center, real world study to evaluate the role of FES-PET in guiding the first-line treatment of HR+/HER2- MBC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FES-guided CDK4/6 inhibitor plus endocrine therapy cohort | – | –The group guided with FES-PET using a CDK4/6 inhibitor plus ET. |
| FES-guided chemotherapy cohort | – | –The group guided with FES-PET using chemotherapy. |
| Non-FES-guided CDK4/6 inhibitor plus endocrine therapy cohort | – | –The group examined without FES-PET using a CDK4/6 inhibitor plus ET. |
| Non-FES-guided chemotherapy cohort | – | –The group examined without FES-PET using chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between January 2020 to February 2024.
Key inclusion criteria (4 listed)
- age >= 18 years old;
- Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between January 2020 to February 2024;
- Received CDK4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle;
- Complete medical history was available.
Key exclusion criteria (1 listed)
- 1. Medical history was incomplete.
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
PFS
Time frame: 6 weeks
progression-free survival
1 secondary outcome
OS
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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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.
Biyun Wang, professor principal investigator
Fudan University
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: finished, as of the sponsor's last update on 7 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PFS (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 7 May 2025.