Trial Title:
Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer
NCT ID:
NCT05486182
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Radiopharmaceuticals
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F Fluoroestradiol Radiopharmaceutical with PET/CT
Description:
Administration of one dose of 18F FES for PET/CT imaging
Arm group label:
Prospective population
Other name:
ESTROTEP
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CGFL
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Recruiting
Contact:
Last name:
Alexandre Cochet, Pr
Phone:
+33 (0) 3 80 73 75 00
Facility:
Name:
CHU Grenoble Alpes
Address:
City:
La Tronche
Zip:
38700
Country:
France
Status:
Recruiting
Contact:
Last name:
Loic DJAÏLEB, Dr
Phone:
+33 (0)4 76 76 54 55
Contact backup:
Last name:
Emmanuelle JACQUET, Dr
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Contact:
Last name:
Sandrine Parisse Di-Martino, Dr
Phone:
+33 (0)4 78 78 28 28
Contact backup:
Last name:
Jean-Yves Blay, Pr
Phone:
+33 (0)4 78 78 28 28
Facility:
Name:
Institut du Cancer de Montpellier
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Recruiting
Contact:
Last name:
Emmanuel Deshayes, Dr
Phone:
+33 (0)4 7 61 31 00
Contact backup:
Last name:
William Jacot, Dr
Phone:
+33 (0)4 7 61 31 00
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Zip:
06189
Country:
France
Status:
Recruiting
Contact:
Last name:
Olivier Humbert, Pr
Phone:
+33 (0)4 92 03 11 14
Contact backup:
Last name:
Jean Marc Ferrero, Pr
Phone:
+33 (0)4 92 03 11 14
Facility:
Name:
Hôpital Tenon
Address:
City:
Paris
Zip:
75020
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75248
Country:
France
Status:
Recruiting
Contact:
Last name:
Audrey Bellesoeur, Dr
Phone:
+33 (0)1 56 24 55 00:
Contact backup:
Last name:
Nina JEHANNO, DR
Facility:
Name:
Institut Curie
Address:
City:
Saint-Cloud
Zip:
92210
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Institut Claudius Regaud Centre de Lutte Contre le Cancer
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Thibault Cassou Mounat, Dr
Phone:
+33 (0)5 31 15 50 50
Contact backup:
Last name:
Florence Dalenc, Dr
Phone:
+33 (0)5 31 15 50 50
Start date:
February 8, 2022
Completion date:
June 2025
Lead sponsor:
Agency:
Zionexa
Agency class:
Industry
Collaborator:
Agency:
GE Healthcare
Agency class:
Industry
Collaborator:
Agency:
Simbec-Orion Group
Agency class:
Industry
Collaborator:
Agency:
Keosys
Agency class:
Other
Source:
Zionexa
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05486182