Informations générales (source: ClinicalTrials.gov)
Impact of 18F-fluoroestradiol (FES) Positron Emission Tomography (PET) on the Therapeutic Treatment of Metastatic Breast Cancer Ipatients, Initially ER Positive and HER2 Negative, in Relapse After First-line Therapy Combining Hormone Therapy (ESTROTIMP)
Interventional
Phase 4
Zionexa (Voir sur ClinicalTrials)
février 2022
juin 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:41 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:27 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Olivier Humbert, Pr | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69008 - Lyon - France | Sandrine Parisse Di-Martino, Dr | Contact (sur clinicalTrials) | |||
| CGFL - 21000 - Dijon - France | Alexandre Cochet, Pr | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - 38700 - La Tronche - France | Loic DJAÏLEB, Dr | Contact (sur clinicalTrials) | |||
| Institut Claudius Regaud Centre de Lutte Contre le Cancer - 31059 - Toulouse - France | Thibault Cassou Mounat, Dr | Contact (sur clinicalTrials) | |||
| Institut du Cancer de Montpellier - 34298 - Montpellier - France | Emmanuel Deshayes, Dr | Contact (sur clinicalTrials) | |||
Critères
Femme
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
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
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