Metastatic Breast CancerNCT04992156
Prediction of 18F-FES-PET/CT Parameters on Palbociclib Combined With ET
An observational study of Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
To investigate parameters based on 18F-FES-PET/CT so as to estimate the outcome of palbociclib combined with endocrine therapy in patients with HR+/HER2-MBC. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Palbociclib
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2017to 15 Apr 2022
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with breast cancer with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
Who may be able to join
- Female patients aged 18-70 years.
- Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- HR+ was defined as estrogen receptor- or progesterone receptor-positive status by immunohistochemistry.
- HER2 status was determined by immunohistochemistry or fluorescence in situ hybridization.
- Palbociclib treatment of metastatic breast cancer for at least one cycle.
- Available medical history.
Who cannot join
- 1.Incomplete medical history.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study of Prediction of 18F-FES-PET/CT Parameters on the Outcome of Palbociclib Combined With Endocrine Therapy in Patients With HR+ and HER2-metastatic Breast Cancer
To investigate parameters based on 18F-FES-PET/CT so as to estimate the outcome of palbociclib combined with endocrine therapy in patients with HR+/HER2-MBC.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Palbociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Palbociclib 125mg/d
| Study group | Role | What they receive |
|---|---|---|
| Patients cohort | Patients with MBC in the Fudan University Shanghai Cancer Center who underwent whole-body 18F-FES PET/CT before the initiation of Palbociclib was included. Receives: Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: Through study completion, an expected average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start15 Mar 2017
- Primary completion15 Mar 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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
- 50 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, Dr, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992156
- Sponsor's protocol ID
- YOUNGBC-15
- Status last verified
- May 2022
- First submitted
- 1 Aug 2021
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu C, Hu S, Xu X, Zhang Y, Wang B, Song S, Yang Z. Evaluation of tumour heterogeneity by 18F-fluoroestradiol PET as a predictive measure in breast cancer patients receiving palbociclib combined with endocrine treatment. Breast Cancer Res. 2022 Aug 26;24(1):57. doi: 10.1186/s13058-022-01555-7.
PubMed 36028895
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Prediction of 18F-FES-PET/CT Parameters on the Outcome of Palbociclib Combined With Endocrine Therapy in Patients With HR+ and HER2-metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04992156
- Acronym / sponsor ID
- YOUNGBC-15
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 5 Aug 2021 (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 investigate parameters based on 18F-FES-PET/CT so as to estimate the outcome of palbociclib combined with endocrine therapy in patients with HR+/HER2-MBC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients cohort | – | Drug: PalbociclibPatients with MBC in the Fudan University Shanghai Cancer Center who underwent whole-body 18F-FES PET/CT before the initiation of Palbociclib was included. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with breast cancer with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
Key inclusion criteria (6 listed)
- Female patients aged 18-70 years.
- Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- HR+ was defined as estrogen receptor- or progesterone receptor-positive status by immunohistochemistry.
- HER2 status was determined by immunohistochemistry or fluorescence in situ hybridization.
- Palbociclib treatment of metastatic breast cancer for at least one cycle.
Key exclusion criteria (1 listed)
- 1.Incomplete medical history.
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 |
|---|---|---|
| PalbociclibPalbociclib 125mg/d | Drug | Patients cohort |
Primary outcome
PFS
Time frame: Through study completion, an expected average of 12 months
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 19 May 2022.
- Derived from this study: PubMed 36028895Liu C, Hu S, Xu X, Zhang Y, Wang B, Song S, Yang Z. Evaluation of tumour heterogeneity by 18F-fluoroestradiol PET as a predictive measure in breast cancer patients receiving palbociclib combined with endocrine treatment. Breast Cancer Res. 2022 Aug 26;24(1):57. doi: 10.1186/s13058-022-01555-7.
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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, Dr 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 Metastatic 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 6 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 19 May 2022. 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: Through study completion, an expected average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04992156, which also lists 1 linked publication.
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 19 May 2022.