Status:
RECRUITING
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
Lead Sponsor:
Centre Georges Francois Leclerc
Conditions:
FES TEP in Detection of Estrogen Receptors
Eligibility:
FEMALE
18+ years
Phase:
NA
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 condit...
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03873428
Start Date
October 18 2021
End Date
October 18 2025
Last Update
February 13 2024
Active Locations (2)
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1
Centre Georges-François Leclerc
Dijon, Bourgogne-Franche-Comté, France, 21000
2
CGFL
Dijon, France, 21079