Phase
Condition
Breast Cancer
Metastatic Cancer
Treatment
18F Fluoroestradiol Radiopharmaceutical with PET/CT
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Female aged at least 18 years old at the time of enrolment
Oestrogen-receptor positive primary breast cancer in IHC (ER ≥10%)
HER2-negative primary breast cancer (0, 1+, 2+ FISH negative)
Metastatic stage with at least one lesion identifiable on the conventional work-upother than a liver lesion
Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormonetherapy
Patient having undergone an FDG PET/CT during follow-up of first-line treatment formetastatic tumour revealing the relapse or undergoing a baseline FDG PET/CT seekingthe relapse during 2nd line staging (according to the recommendations of the Guideto Correct Use (GBU) for medical imaging tests). A period of 2 to 28 days will berespected between the 2 PET/CT scans (FDG/FES).
ECOG 0, 1 or 2
Life expectancy of at least 12 months
Patient registered with a Social Security scheme
Patient having signed an informed consent form
Patient able to follow the study procedures and fill in the quality of lifequestionnaires
Exclusion
Exclusion Criteria:
Isolated hepatic metastases (taking into account the high physiological hepaticuptake of FES)
Patients as first-line treatment for metastatic cancer or aftersecond-line treatmentfor metastatic cancer
Person presenting a known allergy to one of the components of EstroTep
Patients having been treated with a CDK4/6 inhibitor in combination with an SERM orSERD as first-line metastatic therapy
atients suffering from severe or known chronic liver or renal failure
Patient following a low-sodium diet or having alcohol consumption levelsincompatible with the administration of EstroTep, according to the investigator'sopinion
Woman of childbearing age with no effective means of contraception according to theinvestigator's opinion
Severe intercurrent disease or comorbidity assessed at risk
Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the FrenchPublic Health Code
Study Design
Connect with a study center
CGFL
Dijon, 21079
FranceSite Not Available
CHU Grenoble Alpes
La Tronche, 38700
FranceSite Not Available
CHU de Limoges - Dupuytren
Limoges, 87000
FranceSite Not Available
Centre Léon Bérard
Lyon, 69008
FranceSite Not Available
Institut du Cancer de Montpellier
Montpellier, 34298
FranceSite Not Available
Hôpital Américain de Paris
Neuilly-sur-Seine, 92200
FranceSite Not Available
Centre Antoine Lacassagne
Nice, 06189
FranceSite Not Available
Hôpital Tenon
Paris, 75020
FranceSite Not Available
Institut Curie
Paris, 75248
FranceSite Not Available
Institut Curie
Saint-Cloud, 92210
FranceSite Not Available
Institut Claudius Regaud Centre de Lutte Contre le Cancer
Toulouse, 31059
FranceSite Not Available


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