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 (EstroTEPCompar)
Primary Purpose
FES TEP in Detection of Estrogen Receptors
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FES PET
Sponsored by
About this trial
This is an interventional diagnostic trial for FES TEP in Detection of Estrogen Receptors focused on measuring breast cancer, first metastatic relapse, PET
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- CGFL
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
FES PET
Arm Description
1 ) inclusion; 2 ) FGD PET / FES PET; 3) Hormone therapy
Outcomes
Primary Outcome Measures
Estrogen Receptor Gene Expression
number of FDG+ / FES- lesions compared to the number of FDG+ / FES+ lesions
Secondary Outcome Measures
Full Information
NCT ID
NCT03873428
First Posted
March 11, 2019
Last Updated
October 25, 2019
Sponsor
Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT03873428
Brief 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 PET With FES
Acronym
EstroTEPCompar
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).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
FES TEP in Detection of Estrogen Receptors
Keywords
breast cancer, first metastatic relapse, PET
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FES PET
Arm Type
Other
Arm Description
1 ) inclusion; 2 ) FGD PET / FES PET; 3) Hormone therapy
Intervention Type
Other
Intervention Name(s)
FES PET
Intervention Description
FES injection
Primary Outcome Measure Information:
Title
Estrogen Receptor Gene Expression
Description
number of FDG+ / FES- lesions compared to the number of FDG+ / FES+ lesions
Time Frame
at the inclusion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Tabouret-Viaud, MD
Phone
+ 33 3 80 73 75 22
Email
ctabouret@cgfl.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie REDERSTORFF, PhD
Phone
+33(0)3 80 73 75 00
Ext
34 61
Email
ERederstorff@cgfl.fr
Facility Information:
Facility Name
CGFL
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Tabouret-Viaud, MD
Phone
33 3 80 73 75 22
Email
ctabouret@cgfl.fr
First Name & Middle Initial & Last Name & Degree
Emilie REDERSTORFF
Phone
33 3 45 34 81 16
Email
erederstorff@cgfl.fr
12. IPD Sharing Statement
Learn more about this trial
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
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