Clinical trial NCT05486182: Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer
Official title: Impact of 18F-fluoroestradiol (FES) Positron Emission Tomography (PET) on the Therapeutic Treatment of Metastatic Breast Cancer Patients, Initially ER Positive and HER2 Negative, in Relapse After First-line Therapy Combining Hormone Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Metastatic Breast Cancer
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Simbec-Orion Group
name: Keosys
First posted: 2022-08-03
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC).

Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria.

After inclusion, a standardized pre ESTROTEP PET/CT questionnaire will be completed by the investigators to evaluate the initial management plan. Patient will perform the ESTROTEP PET/CT examination at visit 2. A standardized post ESTROTEP PET/CT questionnaire will then be completed by the investigators.

Patients will be followed for 12 months to evaluate their clinical status and standard of care investigations.


Eligibility criteria: Inclusion Criteria:

1. Female aged at least 18 years old at the time of enrolment
2. Oestrogen-receptor positive primary breast cancer in IHC (ER ≥10%)
3. HER2-negative primary breast cancer (0, 1+, 2+ FISH negative)
4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a liver lesion
5. Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormone therapy
6. Patient having undergone an FDG PET/CT during follow-up of first-line treatment for metastatic tumour revealing the relapse or undergoing a baseline FDG PET/CT seeking the relapse during 2nd line staging (according to the recommendations of the Guide to Correct Use (GBU) for medical imaging tests). A period of 2 to 28 days will be respected between the 2 PET/CT scans (FDG/FES).
7. ECOG 0, 1 or 2
8. Life expectancy of at least 12 months
9. Patient registered with a Social Security scheme
10. Patient having signed an informed consent form
11. Patient able to follow the study procedures and fill in the quality of life questionnaires

Exclusion Criteria:

1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)
2. Patients as first-line treatment for metastatic cancer or aftersecond-line treatment for metastatic cancer
3. Person presenting a known allergy to one of the components of EstroTep
4. Patients having been treated with a CDK4/6 inhibitor in combination with an SERM or SERD as first-line metastatic therapy
5. atients suffering from severe or known chronic liver or renal failure
6. Patient following a low-sodium diet or having alcohol consumption levels incompatible with the administration of EstroTep, according to the investigator's opinion
7. Woman of childbearing age with no effective means of contraception according to the investigator's opinion
8. Severe intercurrent disease or comorbidity assessed at risk
9. Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the French Public Health Code

Primary outcomes:
measure: To assess the impact of ESTROTEP PET/CT on metastatic breast cancer patients management, initially ER+ and HER2-, in relapse after first-line treatment combining hormone therapy.
timeFrame: Change from baseline therapeutic measure at 15 days after ESTROTEP PET/CT
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CGFL
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Limoges
country: France
facility: CHU de Limoges - Dupuytren
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
city: Neuilly-sur-Seine
country: France
facility: Hôpital Américain de Paris
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Institut Curie
city: Saint-Cloud
country: France
facility: Institut Curie
city: Toulouse
country: France
facility: Institut Claudius Regaud Centre de Lutte Contre le Cancer
Study officials:
affiliation: Centre Georges Francois Leclerc
name: Alexandre Cochet
role: PRINCIPAL_INVESTIGATOR
References: