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Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer (ESTROTIMP)

Primary Purpose

Metastatic Breast Cancer

Status

Recruiting

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

18F Fluoroestradiol Radiopharmaceutical with PET/CT

About this trial

This is an interventional diagnostic trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Woman aged at least 18 years old on inclusion
Primary breast cancer expressing hormonal estrogen receptors in IHC (ER ≥ 10%)
Primary breast tumor HER2 negative (0, 1+, 2+ FISH negative)
Metastatic stage with at least one lesion identifiable on conventional work-up other than a hepatic lesion
Patient in a situation of recurrence of the first line of treatment combining a CDK4 / 6 inhibitor and a hormone therapy
Patient having performed a PET / CT with FDG during the follow-up of first metastatic line defining the relapse or performing a PET / CT with the baseline FDG defining the relapse during the extension assessment of 2nd line (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).
ECOG 0, 1 or 2
Life expectancy of at least 12 months

Exclusion Criteria:

Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)
Patients in the first metastatic line or beyond the second metastatic line
Person with a known allergy to any of the components of EstroTep
Patients who have been treated with a CDK4 / 6 inhibitor in combination with a first-line metastatic SERM or SERD
Severe or known hepatic or renal failure
Patient under a low salt diet or having an alcohol intake incompatible with EstroTep administration according to the investigator judgment
Woman of childbearing potential without effective contraception according to the investigator judgement
Serious intercurrent illness or co-morbidity assessed as risk

Sites / Locations

CGFLRecruiting
Centre Léon BérardRecruiting
Institut du Cancer de MontpellierRecruiting
Centre Antoine LacassagneRecruiting
Institut Curie
Institut Claudius Regaud Centre de Lutte Contre le CancerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prospective population

Arm Description

Outcomes

Primary Outcome Measures

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.

The percentage of patients for whom a substantial therapeutic measure was implemented following an analysis of the FES PET examination. This assessment will be performed prospectively by means of a standardised questionnaire completed by the prescribing clinician, when the request for an FES PET/CT is made. The therapeutic modality initially planned and the modality actually used may be determined by a multidisciplinary consultation meeting depending on the centre. This questionnaire will completed again within a maximum period of 15 days following the FES PET/CT in order to specify the final therapeutic measure. Substantial measures will be considered to be any major modifications made in terms of: therapeutic modalities, diagnostic modalities and follow-up modalities.

Secondary Outcome Measures

Full Information

NCT ID

NCT05486182

First Posted

March 4, 2022

Last Updated

February 14, 2023

Sponsor

Zionexa

Collaborators

GE Healthcare, Simbec-Orion Group, Keosys

1. Study Identification

Unique Protocol Identification Number

NCT05486182

Brief Title

Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer

Acronym

ESTROTIMP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 8, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zionexa

Collaborators

GE Healthcare, Simbec-Orion Group, Keosys

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Breast Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prospective population

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

18F Fluoroestradiol Radiopharmaceutical with PET/CT

Other Intervention Name(s)

ESTROTEP

Intervention Description

Administration of one dose of 18F FES for PET/CT imaging

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

Change from baseline therapeutic measure at 15 days after ESTROTEP PET/CT

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Woman aged at least 18 years old on inclusion Primary breast cancer expressing hormonal estrogen receptors in IHC (ER ≥ 10%) Primary breast tumor HER2 negative (0, 1+, 2+ FISH negative) Metastatic stage with at least one lesion identifiable on conventional work-up other than a hepatic lesion Patient in a situation of recurrence of the first line of treatment combining a CDK4 / 6 inhibitor and a hormone therapy Patient having performed a PET / CT with FDG during the follow-up of first metastatic line defining the relapse or performing a PET / CT with the baseline FDG defining the relapse during the extension assessment of 2nd line (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). ECOG 0, 1 or 2 Life expectancy of at least 12 months Exclusion Criteria: Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES) Patients in the first metastatic line or beyond the second metastatic line Person with a known allergy to any of the components of EstroTep Patients who have been treated with a CDK4 / 6 inhibitor in combination with a first-line metastatic SERM or SERD Severe or known hepatic or renal failure Patient under a low salt diet or having an alcohol intake incompatible with EstroTep administration according to the investigator judgment Woman of childbearing potential without effective contraception according to the investigator judgement Serious intercurrent illness or co-morbidity assessed as risk

Facility Information:

Facility Name

CGFL

City

Dijon

ZIP/Postal Code

21000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandre Cochet, Pr

Phone

+33 (0) 3 80 73 75 00

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69008

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandrine Parisse Di-Martino, Dr

Phone

+33 (0)4 78 78 28 28

First Name & Middle Initial & Last Name & Degree

Jean-Yves Blay, Pr

Phone

+33 (0)4 78 78 28 28

Facility Name

Institut du Cancer de Montpellier

City

Montpellier

ZIP/Postal Code

34298

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emmanuel Deshayes, Dr

Phone

+33 (0)4 7 61 31 00

First Name & Middle Initial & Last Name & Degree

William Jacot, Dr

Phone

+33 (0)4 7 61 31 00

Facility Name

Centre Antoine Lacassagne

City

Nice

ZIP/Postal Code

06189

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier Humbert, Pr

Phone

+33 (0)4 92 03 11 14

First Name & Middle Initial & Last Name & Degree

Jean Marc Ferrero, Pr

Phone

+33 (0)4 92 03 11 14

Facility Name

Institut Curie

City

Saint-Cloud

ZIP/Postal Code

92210

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Institut Claudius Regaud Centre de Lutte Contre le Cancer

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thibault Cassou Mounat, Dr

Phone

+33 (0)5 31 15 50 50

First Name & Middle Initial & Last Name & Degree

Florence Dalenc, Dr

Phone

+33 (0)5 31 15 50 50

12. IPD Sharing Statement

Learn more about this trial

Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer

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