Metastatic Breast CancerTEP-FESNCT03442504
Prediction of Response to 2nd-line Hormone Therapy by FES CT/PET in Patients With Metastatic Breast Cancer
A study testing FES PET/CT in people with Metastatic Breast Cancer, run by Institut Cancerologie de l'Ouest at 4 sites in France.
Trial summary
Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who is progressing after first-line hormonal therapy if the initial disease was RH + with an increase in survival without recurrence more or less long. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- FES PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Mar 2017to Jun 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary breast tumor (ductal or lobular) expressing immunohistochemistry of hormone receptors (RP + and / or RE +, with significance level ≥ 10%) but not overexpressing HER2,
- Metastatic stage with at least one lesion identifiable on the conventional balance sheet other than a liver injury,
- Patient progressing under a 1st line of hormone therapy,
- Patient candidate for a new second-line hormonal treatment,
- Postmenopausal patient,
- Karnofsky ≥ 70 or ECOG 0-1
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- Life expectancy of at least 6 months
- Creatinine <= 2.5 normal
- Social insured patient
- Signed informed consent
Who cannot join
- HER2 overexpressing primary tumor in immunohistochemistry,
- Tumor that does not significantly (<10%) express the hormonal receptors,
- Hormonal treatment in progress,
- Contraindication to a new second-line hormonal treatment,
- Patient receiving or likely to receive second-line chemotherapy in the course of the evolution of her breast cancer,
- Persons deprived of liberty or guardianship,
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- Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons,
- Serious illness or comorbidity assessed at risk,
- History of cancer within 5 years, with the exception of cutaneous carcinomas other than melanomas, or carcinoma in situ of the cervix,
- Intellectual inability to sign informed consent.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Institut de Cancerologie de l'Ouest
Angers, 49055
CHU de Brest
Brest, 29200
Centre Georges François Leclerc
Dijon, 21079
ICO René Gauducheau
Saint-Herblain, 44805
About this study
Official title: Evaluation Study of the Prediction of the Response to Second-line Hormone Therapy by 16α- [18F] Fluoro-17β-estradiol (FES) PET in Patients With Metastatic Breast Cancer
Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who is progressing after first-line hormonal therapy if the initial disease was RH + with an increase in survival without recurrence more or less long. The biopsy of the metastatic site or sites is rarely performed because of the heaviness of the gesture. Clinicians are waiting for imaging, which can replace biopsy before the second-line metastatic hormone treatment in breast cancer, which will reveal the metastatic lesion heterogeneity allowing to establish if hormone therapy is the best therapeutic option for these patients and therefore lead to a personalized medicine driven by PET FES. This imaging approach seems all the more interesting as ER expression appears to evolve over time under the pressure of treatment or the natural evolution of carcinomas.
Currently, no studies in breast cancer, in an ER + population on the initial tumor and Her2 negative, are listed for the study of ER expression by PET FES before a second metastatic hormone treatment line.
Read the detailed description
Approximately 70% of breast cancer patients have estrogen-receptor-expressing tumors, making hormone therapy an attractive option for adjuvant and metastatic treatment. The expression of estrogen receptors is modified during the course of treatment. Tumor development, there is a discrepancy between primary tumors and metastases from 14.5% to 40% of cases. Biopsies are useful for reassessing a patient's "estrogen receptor" status, but it is not always feasible especially at the stage of multiple metastases and the gesture remains invasive.
The sensitivity and specificity of PET FES has been studied in patients with "estrogen-positive receptor" breast cancer lesions. Sensitivity was good except for liver metastases due to physiological binding of this tracer to the liver. Quantification of FES binding was correlated with expression of estrogen receptors visualized in IHC. Metastases could be seen with FES in the bone, lung and lymph nodes and more difficult in the liver.
Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who is progressing after first-line hormonal therapy if the initial disease was RH + with an increase in survival without recurrence more or less long. The biopsy of the metastatic site or sites is rarely performed because of the heaviness of the gesture. Clinicians are waiting for imaging, which can replace biopsy before the second-line metastatic hormone treatment in breast cancer, which will reveal the metastatic lesion heterogeneity allowing to establish if hormone therapy is the best therapeutic option for these patients and therefore lead to a personalized medicine driven by PET FES. This imaging approach seems all the more interesting as ER expression appears to evolve over time under the pressure of treatment or the natural evolution of carcinomas.
Currently, no studies in breast cancer, in an ER + population on the initial tumor and Her2 negative, are listed for the study of ER expression by PET FES before a second metastatic hormone treatment line.
- Conditions
- Metastatic Breast Cancer
- Being tested
- FES PET/CT
- Keywords
- metastatic Breast cancer, FES PET/CT, menopausal patients, recurrence after a 1st line of hormone therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES PET/CTDiagnostic test
There will be no premedication or other treatment before and after PET FES. PET / CT will be performed at the center level on a hybrid PET camera.
- The first TEP FES acquisition begins at the time of injection and continues for 30 minutes,
- The second acquisition of 20 minutes takes place 60 minutes after the injection is a total of 50 minutes of imaging and 1:30 in the service.
| Study group | Role | What they receive |
|---|---|---|
| FES PET/CT | Other | The images will be made immediately after the injection of the FES in a dynamic acquisition, of 30 minutes, centered on a positive FDG lesion. The imaging will then be completed 1 hour after the injection, after obtaining a urination, by an acquisition "whole body" (from the top of the skull to the root of the thighs or more if element on FDG or conventional imaging) which will be performed in the supine position with arms around the body. During the PET / CT scan, patients will breathe spontaneously. The acquisition will last 30 minutes. Receives: Diagnostic Test: FES PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the predictive value of PET at the "lesion" level
Determine the predictive value of PET at the "lesion" level, before a second-line hormonal treatment on the response obtained at 6 weeks of treatment.
Measured: 6 weeks
Secondary outcomes (1)
Determine the predictive value of PET at FES at the "patient" level
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start15 Mar 2017
- Primary completion11 Jan 2023
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline ROUSSEAU, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442504
- Sponsor's protocol ID
- ICO-N-2016-02
- Acronym
- TEP-FES
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2018
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study of the Prediction of the Response to Second-line Hormone Therapy by 16α- [18F] Fluoro-17β-estradiol (FES) PET in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03442504
- Acronym / sponsor ID
- TEP-FES / ICO-N-2016-02
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic Breast cancer, FES PET/CT, menopausal patients, recurrence after a 1st line of hormone therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 22 Feb 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.
Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who is progressing after first-line hormonal therapy if the initial disease was RH + with an increase in survival without recurrence more or less long. The biopsy of the metastatic site or sites is rarely performed because of the heaviness of the gesture. Clinicians are waiting for imaging, which can replace biopsy before the second-line metastatic hormone treatment in breast cancer, which will reveal the metastatic lesion heterogeneity allowing to establish if hormone therapy is the best therapeutic option for these patients and therefore lead to a personalized medicine driven by PET FES. This imaging approach seems all the more interesting as ER expression appears to evolve over time under the pressure of treatment or the natural evolution of carcinomas.
Currently, no studies in breast cancer, in an ER + population on the initial tumor and Her2 negative, are listed for the study of ER expression by PET FES before a second metastatic hormone treatment line.
Detailed description
Approximately 70% of breast cancer patients have estrogen-receptor-expressing tumors, making hormone therapy an attractive option for adjuvant and metastatic treatment. The expression of estrogen receptors is modified during the course of treatment. Tumor development, there is a discrepancy between primary tumors and metastases from 14.5% to 40% of cases. Biopsies are useful for reassessing a patient's "estrogen receptor" status, but it is not always feasible especially at the stage of multiple metastases and the gesture remains invasive.
The sensitivity and specificity of PET FES has been studied in patients with "estrogen-positive receptor" breast cancer lesions. Sensitivity was good except for liver metastases due to physiological binding of this tracer to the liver. Quantification of FES binding was correlated with expression of estrogen receptors visualized in IHC. Metastases could be seen with FES in the bone, lung and lymph nodes and more difficult in the liver.
Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who is progressing after first-line hormonal therapy if the initial disease was RH + with an increase in survival without recurrence more or less long. The biopsy of the metastatic site or sites is rarely performed because of the heaviness of the gesture. Clinicians are waiting for imaging, which can replace biopsy before the second-line metastatic hormone treatment in breast cancer, which will reveal the metastatic lesion heterogeneity allowing to establish if hormone therapy is the best therapeutic option for these patients and therefore lead to a personalized medicine driven by PET FES. This imaging approach seems all the more interesting as ER expression appears to evolve over time under the pressure of treatment or the natural evolution of carcinomas.
Currently, no studies in breast cancer, in an ER + population on the initial tumor and Her2 negative, are listed for the study of ER expression by PET FES before a second metastatic hormone treatment line.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES PET/CT | Other | Diagnostic Test: FES PET/CTThe images will be made immediately after the injection of the FES in a dynamic acquisition, of 30 minutes, centered on a positive FDG lesion. The imaging will then be completed 1 hour after the injection, after obtaining a urination, by an acquisition "whole body" (from the top of the skull to the root of the thighs or more if element on FDG or conventional imaging) which will be performed in the supine position with arms around the body. During the PET / CT scan, patients will breathe spontaneously. The acquisition will last 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Primary breast tumor (ductal or lobular) expressing immunohistochemistry of hormone receptors (RP + and / or RE +, with significance level ≥ 10%) but not overexpressing HER2,
- Metastatic stage with at least one lesion identifiable on the conventional balance sheet other than a liver injury,
- Patient progressing under a 1st line of hormone therapy,
- Patient candidate for a new second-line hormonal treatment,
- Postmenopausal patient,
Key exclusion criteria (10 listed)
- HER2 overexpressing primary tumor in immunohistochemistry,
- Tumor that does not significantly (<10%) express the hormonal receptors,
- Hormonal treatment in progress,
- Contraindication to a new second-line hormonal treatment,
- Patient receiving or likely to receive second-line chemotherapy in the course of the evolution of her breast cancer,
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 |
|---|---|---|
| FES PET/CTThere will be no premedication or other treatment before and after PET FES. PET / CT will be performed at the center level on a hybrid PET camera. * The first TEP FES acquisition begins at the time of injection and continues for 30 minutes, * The second acquisition of 20 minutes takes place 60 minutes after the injection is a total of 50 minutes of imaging and 1:30 in the service. | Diagnostic test | FES PET/CT |
Primary outcome
Determine the predictive value of PET at the "lesion" level
Time frame: 6 weeks
Determine the predictive value of PET at the "lesion" level, before a second-line hormonal treatment on the response obtained at 6 weeks of treatment.
1 secondary outcome
Determine the predictive value of PET at FES at the "patient" level
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Caroline ROUSSEAU, MD principal investigator
Institut de Cancérologie de l'Ouest
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES PET/CT in people with Metastatic Breast Cancer, run by Institut Cancerologie de l'Ouest at 4 sites in France.
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 10 inclusion and 10 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
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?
Determine the predictive value of PET at the "lesion" level (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 12 Mar 2024.