Prediction of Response to 2nd-line Hormone Therapy by FES CT/PET in Patients With Metastatic Breast Cancer

NCT03442504 | Active Not Recruiting

• 1 other identifier: ICO-N-2016-02
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 4

Brief Summary

Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who is progressing after first-line hormonal therapy if the initial disease was RH + with an increase in survival without recurrence more or less long. The biopsy of the metastatic site or sites is rarely performed because of the heaviness of the gesture. Clinicians are waiting for imaging, which can replace biopsy before the second-line metastatic hormone treatment in breast cancer, which will reveal the metastatic lesion heterogeneity allowing to establish if hormone therapy is the best therapeutic option for these patients and therefore lead to a personalized medicine driven by PET FES. This imaging approach seems all the more interesting as ER expression appears to evolve over time under the pressure of treatment or the natural evolution of carcinomas. Currently, no studies in breast cancer, in an ER + population on the initial tumor and Her2 negative, are listed for the study of ER expression by PET FES before a second metastatic hormone treatment line.

Conditions

Metastatic Breast Cancer

Keywords

metastatic Breast cancer; FES PET/CT; menopausal patients; recurrence after a 1st line of hormone therapy

Outcome Measures

Primary Outcomes (1)

• Determine the predictive value of PET at the "lesion" level

  Determine the predictive value of PET at the "lesion" level, before a second-line hormonal treatment on the response obtained at 6 weeks of treatment.

  6 weeks

Secondary Outcomes (1)

• Determine the predictive value of PET at FES at the "patient" level

  1 year

Study Arms (1)

FES PET/CT

OTHER

The images will be made immediately after the injection of the FES in a dynamic acquisition, of 30 minutes, centered on a positive FDG lesion. The imaging will then be completed 1 hour after the injection, after obtaining a urination, by an acquisition "whole body" (from the top of the skull to the root of the thighs or more if element on FDG or conventional imaging) which will be performed in the supine position with arms around the body. During the PET / CT scan, patients will breathe spontaneously. The acquisition will last 30 minutes.

Diagnostic Test: FES PET/CT

Interventions

FES PET/CT DIAGNOSTIC_TEST

There will be no premedication or other treatment before and after PET FES. PET / CT will be performed at the center level on a hybrid PET camera. * The first TEP FES acquisition begins at the time of injection and continues for 30 minutes, * The second acquisition of 20 minutes takes place 60 minutes after the injection is a total of 50 minutes of imaging and 1:30 in the service.

FES PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary breast tumor (ductal or lobular) expressing immunohistochemistry of hormone receptors (RP + and / or RE +, with significance level ≥ 10%) but not overexpressing HER2,
• Metastatic stage with at least one lesion identifiable on the conventional balance sheet other than a liver injury,
• Patient progressing under a 1st line of hormone therapy,
• Patient candidate for a new second-line hormonal treatment,
• Postmenopausal patient,
• Karnofsky ≥ 70 or ECOG 0-1
• Life expectancy of at least 6 months
• Creatinine \<= 2.5 normal
• Social insured patient
• Signed informed consent

You may not qualify if:

• HER2 overexpressing primary tumor in immunohistochemistry,
• Tumor that does not significantly (\<10%) express the hormonal receptors,
• Hormonal treatment in progress,
• Contraindication to a new second-line hormonal treatment,
• Patient receiving or likely to receive second-line chemotherapy in the course of the evolution of her breast cancer,
• Persons deprived of liberty or guardianship,
• Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons,
• Serious illness or comorbidity assessed at risk,
• History of cancer within 5 years, with the exception of cutaneous carcinomas other than melanomas, or carcinoma in situ of the cervix,
• Intellectual inability to sign informed consent.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (4)

Institut de Cancerologie de l'Ouest

Angers, 49055, France

Location

CHU de Brest

Brest, 29200, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

ICO René Gauducheau

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Caroline ROUSSEAU, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: March 15, 2017
• Primary Completion: January 11, 2023
• Study Completion: June 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-02

Locations

FR (4)