Impact of 18F-FES TEP on therapeutical management in patients with metastatic breast cancer, ER positive and HER2 negative, in relapse after a first line of treatment combining hormonal therapy

Phase 1

• Conditions: Patients with metastatic breast cancer initially presenting with overexpression of estrogen receptors (ERs) and absence of overexpression of HER2, relapsing after a first therapeutic line combining hormone therapy.; MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2021-003601-21-FR
• Lead Sponsor: Zionexa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-19
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

1. Woman aged at least 18 years old on inclusion
2. Primary breast cancer expressing hormonal estrogen receptors in IHC (ER = 10%)
3. Primary breast tumor HER2 negative (0, 1+, 2+ FISH negative)
4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a hepatic lesion
5. Patient in a situation of recurrence of the first line of treatment combining a CDK4 / 6 inhibitor and a hormone therapy
6.Patient having performed a PET / CT with FDG during the follow-up of the first metastatic line defining the relapse or accepting to perform a PET / CT with the baseline FDG for the extension assessment (according to the recommendations of the GBU of the examinations of 'medical imaging). A period of 2 to 28 days will be respected between the 2 PET / CT (FDG / FES).
7.ECOG 0, 1 or 2
8. Life expectancy of at least 12 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)
2. Patients in the first metastatic line or beyond the second metastatic line
3. Person with a known allergy to any of the components of EstroTep
4. Patients who have been treated with a CDK4 / 6 inhibitor in combination with a first-line metastatic SERM or SERD
5. Woman of childbearing potential without effective contraception
6. Serious intercurrent illness or co-morbidity assessed as risk

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified