FES TEP in Detection of Estrogen ReceptorsEstroTEPComparNCT03873428
Evaluation of the Unconformity of the Hormonal Status of Metastatic Lesions During a First Relapse of Breast Cancer Initially Expressing Estrogen Receptors: a Pilot Study on the Interest of PET With FES
A study testing FES PET in people with FES TEP in Detection of Estrogen Receptors, run by Centre Georges Francois Leclerc at 2 sites in France.
Trial summary
Breast cancer is a major public health issue despite therapeutic advances, it is the first cause of death cancer of women in Europe. Several treatments may be proposed depending on the general condition of the patient, the characteristics of the initial tumor and the stage of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- FES TEP in Detection of Estrogen Receptors
- What is being tested?
- FES PET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Oct 2021to 18 Oct 2025
- 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
- ECOG score (Eastern Cooperative Oncology Group) ≤ 2.
- Stage IV breast cancer (AJCC TNM).
- Primitive tumor expressing RO (> 10%).
- Patient candidate for hormone therapy treatment targeting estrogen receptors as a first-line treatment in a context of first metastatic recurrence.
- No overexpression of HER2 in the tumor.
- Lack of previous treatment for metastatic disease
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- Metastatic status confirmed by 18F-FDG PET / CT performed in the month prior to inclusion
- Life expectancy estimated at more than 3 months.
- Patient able to understand and give informed informed consent for participation in the study.
- Patient affiliated with the social security scheme or equivalent.
Who cannot join
- Triple negative breast cancer
- Overexpression HER2 +++
- Metastatic involvement exclusively in the liver
- Unable to lie down or maintain the position during the PET / CT scan
- Uncontrolled intercurrent pathology that is life-threatening in the short term
- Uncontrolled diabetes
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- History of an allergic reaction attributed to a chemical or biological compound related to FDG or FES
- Psychiatric impairment or social conditions that would limit patient availability and compliance at different stages of the study.
- Pregnant woman (mandatory pregnancy test at baseline) or who is breastfeeding.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre Georges-François Leclerc
Dijon, Bourgogne-Franche-Comté, 21000
Jean-Louis ALBERINI, Pr, 03 80 73 75 22 ext. §33, JLAlberini@cgfl.fr
- Not yet recruiting
CGFL
Dijon, 21079
Claire Tabouret-Viaud, MD, 33 3 80 73 75 22, ctabouret@cgfl.fr
Emilie REDERSTORFF, 33 3 45 34 81 16, erederstorff@cgfl.fr
About this study
Official title: Evaluation of the Unconformity of the Hormonal Status of Metastatic Lesions During a First Relapse of Breast Cancer Initially Expressing Estrogen Receptors: a Pilot Study on the Interest of Positron Emission Tomography (PET) With 16α- [18F] -Fluoro-17β-estradiol (FES).
Breast cancer is a major public health issue despite therapeutic advances, it is the first cause of death cancer of women in Europe.
Several treatments may be proposed depending on the general condition of the patient, the characteristics of the initial tumor and the stage of the disease. The different treatments in metastatic relapse of hormone receptor-positive breast cancer are systemic treatments, such as hormone therapy, chemotherapy, targeted therapies, and possible supportive care, but also in some cases local treatments such as surgery and radiotherapy.
Read more
Comparative analysis of primary mammary tumors and their metastases has demonstrated the essential role of tumor heterogeneity, both in time and space, in the progression of the disease and the occurrence of resistance to treatments. Taking into account this intratumoral heterogeneity represents a major axis of improvement in the management of patients with breast cancer.
The use of innovative radiotracers such as 16α- [18F] -fluoro-17β-estradiol (FES) may allow in the future to better evaluate this tumor heterogeneity in patients with metastatic breast cancer through non-metastatic characterization. invasive different lesions. It will be possible to propose to each patient a more personalized care with possibly the administration, in addition to the systemic treatment, of a local treatment adapted to the characteristics of some secondary lesions likely to respond less well to the systemic treatment.
In this pilot study, the investigators would like to estimate the number of patients and the number of metastatic sites affected by tumor heterogeneity of estrogen receptor expression, which could benefit from specific management.
This study will concern a population of patients with first metastatic recurrence of hormone receptor-positive breast cancer initially, with at least one metastasis, who are candidates for treatment with hormone therapy.
Read the detailed description
The main objective of this pilot study is to determine the unconformity rates for estrogen receptor expression in different metastatic lesions in patients with first metastatic recurrence of breast cancer initially expressing estrogen receptors.
Secondary objectives are:
- To study the influence of the FES PET could have for possible modifications of therapeutic management in these patients.
- Determine the rate of patients with additional positive FES lesions but without positive FDG lesions.
- Evaluate the response to chemotherapy at 3 months after using FDG-PET in clinical routine.
- Being tested
- FES PET
- Keywords
- breast cancer, first metastatic relapse, PET
- 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 PETOther
FES injection
| Study group | Role | What they receive |
|---|---|---|
| FES PET | Other | 1 ) inclusion; 2 ) FGD PET / FES PET; 3) Hormone therapy Receives: Other: FES PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estrogen Receptor Gene Expression
number of FDG+ / FES- lesions compared to the number of FDG+ / FES+ lesions
Measured: at the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start18 Oct 2021
- Primary completion18 Oct 2025 (estimated)
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FES TEP in Detection of Estrogen ReceptorsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873428
- Sponsor's protocol ID
- EstroTEP COMPARE
- Acronym
- EstroTEPCompar
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2019
- Last updated
- 13 Feb 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Unconformity of the Hormonal Status of Metastatic Lesions During a First Relapse of Breast Cancer Initially Expressing Estrogen Receptors: a Pilot Study on the Interest of Positron Emission Tomography (PET) With 16α- [18F] -Fluoro-17β-estradiol (FES).
- ClinicalTrials.gov ID
- NCT03873428
- Acronym / sponsor ID
- EstroTEPCompar / EstroTEP COMPARE
- Keywords
- breast cancer, first metastatic relapse, PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 18 Oct 2025 (estimated)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 13 Mar 2019 (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.
Breast cancer is a major public health issue despite therapeutic advances, it is the first cause of death cancer of women in Europe.
Several treatments may be proposed depending on the general condition of the patient, the characteristics of the initial tumor and the stage of the disease. The different treatments in metastatic relapse of hormone receptor-positive breast cancer are systemic treatments, such as hormone therapy, chemotherapy, targeted therapies, and possible supportive care, but also in some cases local treatments such as surgery and radiotherapy.
Comparative analysis of primary mammary tumors and their metastases has demonstrated the essential role of tumor heterogeneity, both in time and space, in the progression of the disease and the occurrence of resistance to treatments. Taking into account this intratumoral heterogeneity represents a major axis of improvement in the management of patients with breast cancer.
The use of innovative radiotracers such as 16α- [18F] -fluoro-17β-estradiol (FES) may allow in the future to better evaluate this tumor heterogeneity in patients with metastatic breast cancer through non-metastatic characterization. invasive different lesions. It will be possible to propose to each patient a more personalized care with possibly the administration, in addition to the systemic treatment, of a local treatment adapted to the characteristics of some secondary lesions likely to respond less well to the systemic treatment.
In this pilot study, the investigators would like to estimate the number of patients and the number of metastatic sites affected by tumor heterogeneity of estrogen receptor expression, which could benefit from specific management.
This study will concern a population of patients with first metastatic recurrence of hormone receptor-positive breast cancer initially, with at least one metastasis, who are candidates for treatment with hormone therapy.
Detailed description
The main objective of this pilot study is to determine the unconformity rates for estrogen receptor expression in different metastatic lesions in patients with first metastatic recurrence of breast cancer initially expressing estrogen receptors.
Secondary objectives are:
- To study the influence of the FES PET could have for possible modifications of therapeutic management in these patients.
- Determine the rate of patients with additional positive FES lesions but without positive FDG lesions.
- Evaluate the response to chemotherapy at 3 months after using FDG-PET in clinical routine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES PET | Other | Other: FES PET1 ) inclusion; 2 ) FGD PET / FES PET; 3) Hormone therapy |
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)
- ECOG score (Eastern Cooperative Oncology Group) ≤ 2.
- Stage IV breast cancer (AJCC TNM).
- Primitive tumor expressing RO (> 10%).
- Patient candidate for hormone therapy treatment targeting estrogen receptors as a first-line treatment in a context of first metastatic recurrence.
- No overexpression of HER2 in the tumor.
Key exclusion criteria (9 listed)
- Triple negative breast cancer
- Overexpression HER2 +++
- Metastatic involvement exclusively in the liver
- Unable to lie down or maintain the position during the PET / CT scan
- Uncontrolled intercurrent pathology that is life-threatening in the short term
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 PETFES injection | Other | FES PET |
Primary outcome
Estrogen Receptor Gene Expression
Time frame: at the inclusion
number of FDG+ / FES- lesions compared to the number of FDG+ / FES+ lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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.
2 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 in people with FES TEP in Detection of Estrogen Receptors, run by Centre Georges Francois Leclerc at 2 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 9 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Claire Tabouret-Viaud, MD (+ 33 3 80 73 75 22, ctabouret@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estrogen Receptor Gene Expression (time frame: at the inclusion). 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 13 Feb 2024.