Estrogen Receptor-positive Breast CancerPETNCT03768479
The Value of 18F-FES-PET/CT in Predicting Fulvestrant Efficacy in Breast Cancer
A study testing 18F-FES-PET in people with Estrogen Receptor-positive Breast Cancer and Fulvestrant, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study is focused on the value of 18F-FES-PET in predicting the Fulvestrant efficacy in hormone receptor-positive breast cancer. The imaging agent involved in this study is 16α-[18F]-fluoro-17β-estradiol (18F-FES). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Estrogen Receptor-positive Breast Cancer, Fulvestrant
- What is being tested?
- 18F-FES-PET
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2017to Mar 2019
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years or older (required for legal consent)
- Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Pathologically diagnosed metastatic breast cancer
- Fulvestrant used as the first-line treatment
- Have primary breast tumor that is at least 2 cm in diameter as measured in any dimension on either mammogram, ultrasound, or breast MRI
- Have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- General Exclusion Criteria
- Previously treated metastatic breast cancer
- Concurrent malignancy of any type
- Impaired elimination (as defined as having problems with urination)
- Participation in a research study/studies involving radiation exposure within the past 12 months
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, major kidney or liver disease, or psychiatric illness/social situations that would limit compliance with study requirements
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- Pregnancy
- Currently lactating (either breast feeding or breast pumping)
- General PET/CT Safety Exclusion Criteria:
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, ferromagnetic objects such as jewelry or metal clips in clothing
- Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
- Inability to lie comfortably on a bed inside a PET camera for 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis)
- Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure for female subjects of child-bearing age.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Jin Yang, 0086-029-85324600, yangjin@xjtu.edu.cn
About this study
Official title: The Value of 18F-FES-PET/CT in Predicting the Efficacy of Fulvestrant as First-line Treatment in Postmenopausal Patients With Hormone Receptor-positive Advanced Breast Cancer - a Multicenter Prospective Study
This study is focused on the value of 18F-FES-PET in predicting the Fulvestrant efficacy in hormone receptor-positive breast cancer. The imaging agent involved in this study is 16α-[18F]-fluoro-17β-estradiol (18F-FES).
Read the detailed description
This study is an open, multi-center and prospective clinical study, It is the first time investigators are examining this imaging agent in Chinese patients with breast cancer.
The Chinese FDA has approved 18F-FES as an investigational tracer in a selective few research studies. The Chinese FDA has not approved this tracer for any use outside of research. In this research study, the investigators are investigating the use of a PET tracer called 18F-FES in patients with breast cancer.
The purpose is to take images that can measure the amount of a protein called Estrogen Receptor, or 'ER' in breast tumors. The expression level of ER is tightly correlated with the Fulvestrant efficacy in patients with breast cancer. The investigators will take the pictures of the participant's residual tumor lesions using a PET/CT scanner with 18F-FES used as the tracer before and after the first cycle of Fulvestrant treatment. The investigators are trying to clarify the relationship between the clinical Fulvestrant efficacy and the amount change of 18F-FES uptake by breast tumor around the first cycle of Fulvestrant treatment.
This could help them to predict the efficacy of endocrine therapy by monitoring the dynamic levels of ER in advance, and potentially help guide treatment of breast tumors in the future.
18F-FES was initially developed to image the primary breast tumor. In previous studies of 18F-FES conducted in humans, there were no adverse events (there have been no problems). While this is not the first time 18F-FES has been used in humans, it is the first study in which the investigators study its predictive value in the treatment efficacy in breast cancer.
- Being tested
- 18F-FES-PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FES-PETDevice
18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant
| Study group | Role | What they receive |
|---|---|---|
| FES-Fulvestrant | Experimental | Patients with ER positive breast cancer receive Fulvestrant as the first line treatment enrolled in the study would receive 18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant. Receives: Device: 18F-FES-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change percentage of 18F-FES SUV
The change percentage of 18F-FES standard uptake value (SUV) before and after cycle 1 of Fulvestrant treatment
Measured: At end of cycle 1 of Fulvestrant treatment (each cycle is 28 days)
Secondary outcomes (1)
The correlation between the change percentage of 18F-FES SUV and the clinical efficacy
To find the correlation between the change percentage of 18F-FES SUV and the clinical efficacy, and further to determine the cutoff of 18F-FES SUV change percentage that could predict beneficial efficacy of Fulvestrant in breast cancer
Measured: From the enrollment time to the time of disease progression or 2 years' followup which comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start5 Mar 2017
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
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 Estrogen Receptor-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin Yang, Principal investigator, First Affiliated Hospital of Xi'an Jiaotong UJin Jin, Principal investigator, First Affiliated Hospital of Xi'an Jiaotong U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768479
- Sponsor's protocol ID
- XJTU1AF-CRF-2016-020
- Acronym
- PET
- Status last verified
- Jun 2018
- First submitted
- 26 Nov 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Kruchten M, de Vries EG, Glaudemans AW, van Lanschot MC, van Faassen M, Kema IP, Brown M, Schroder CP, de Vries EF, Hospers GA. Measuring residual estrogen receptor availability during fulvestrant therapy in patients with metastatic breast cancer. Cancer Discov. 2015 Jan;5(1):72-81. doi: 10.1158/2159-8290.CD-14-0697. Epub 2014 Nov 7.
PubMed 25380844
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of 18F-FES-PET/CT in Predicting the Efficacy of Fulvestrant as First-line Treatment in Postmenopausal Patients With Hormone Receptor-positive Advanced Breast Cancer - a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT03768479
- Acronym / sponsor ID
- PET / XJTU1AF-CRF-2016-020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 7 Dec 2018 (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 is focused on the value of 18F-FES-PET in predicting the Fulvestrant efficacy in hormone receptor-positive breast cancer. The imaging agent involved in this study is 16α-[18F]-fluoro-17β-estradiol (18F-FES).
Detailed description
This study is an open, multi-center and prospective clinical study, It is the first time investigators are examining this imaging agent in Chinese patients with breast cancer.
The Chinese FDA has approved 18F-FES as an investigational tracer in a selective few research studies. The Chinese FDA has not approved this tracer for any use outside of research. In this research study, the investigators are investigating the use of a PET tracer called 18F-FES in patients with breast cancer.
The purpose is to take images that can measure the amount of a protein called Estrogen Receptor, or 'ER' in breast tumors. The expression level of ER is tightly correlated with the Fulvestrant efficacy in patients with breast cancer. The investigators will take the pictures of the participant's residual tumor lesions using a PET/CT scanner with 18F-FES used as the tracer before and after the first cycle of Fulvestrant treatment. The investigators are trying to clarify the relationship between the clinical Fulvestrant efficacy and the amount change of 18F-FES uptake by breast tumor around the first cycle of Fulvestrant treatment.
This could help them to predict the efficacy of endocrine therapy by monitoring the dynamic levels of ER in advance, and potentially help guide treatment of breast tumors in the future.
18F-FES was initially developed to image the primary breast tumor. In previous studies of 18F-FES conducted in humans, there were no adverse events (there have been no problems). While this is not the first time 18F-FES has been used in humans, it is the first study in which the investigators study its predictive value in the treatment efficacy in breast cancer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES-Fulvestrant | Experimental | Device: 18F-FES-PETPatients with ER positive breast cancer receive Fulvestrant as the first line treatment enrolled in the study would receive 18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 18 years or older (required for legal consent)
- Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Pathologically diagnosed metastatic breast cancer
- Fulvestrant used as the first-line treatment
- Have primary breast tumor that is at least 2 cm in diameter as measured in any dimension on either mammogram, ultrasound, or breast MRI
Key exclusion criteria (14 listed)
- General Exclusion Criteria
- Previously treated metastatic breast cancer
- Concurrent malignancy of any type
- Impaired elimination (as defined as having problems with urination)
- Participation in a research study/studies involving radiation exposure within the past 12 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 |
|---|---|---|
| 18F-FES-PET18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant | Device | FES-Fulvestrant |
Primary outcome
the change percentage of 18F-FES SUV
Time frame: At end of cycle 1 of Fulvestrant treatment (each cycle is 28 days)
The change percentage of 18F-FES standard uptake value (SUV) before and after cycle 1 of Fulvestrant treatment
1 secondary outcome
The correlation between the change percentage of 18F-FES SUV and the clinical efficacy
Time frame: From the enrollment time to the time of disease progression or 2 years' followup which comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Results publication: PubMed 25380844van Kruchten M, de Vries EG, Glaudemans AW, van Lanschot MC, van Faassen M, Kema IP, Brown M, Schroder CP, de Vries EF, Hospers GA. Measuring residual estrogen receptor availability during fulvestrant therapy in patients with metastatic breast cancer. Cancer Discov. 2015 Jan;5(1):72-81. doi: 10.1158/2159-8290.CD-14-0697. Epub 2014 Nov 7.
- 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.
Jin Yang principal investigator
First Affiliated Hospital of Xi'an Jiaotong U
Jin Jin principal investigator
First Affiliated Hospital of Xi'an Jiaotong U
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-FES-PET in people with Estrogen Receptor-positive Breast Cancer and Fulvestrant, run by First Affiliated Hospital Xi'an Jiaotong 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 14 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: status not confirmed, as of the sponsor's last update on 11 Dec 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Yang (0086-029-85324600, yangjin@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change percentage of 18F-FES SUV (time frame: At end of cycle 1 of Fulvestrant treatment (each cycle is 28 days)). 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 NCT03768479, 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 11 Dec 2018.