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

Primary Purpose

Metastatic Breast Cancer

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FES PET/CT
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metastatic Breast Cancer focused on measuring metastatic Breast cancer, FES PET/CT, menopausal patients, recurrence after a 1st line of hormone therapy

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Institut de Cancerologie de l'Ouest
  • CHU de Brest
  • Centre Georges François Leclerc
  • ICO René Gauducheau

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FES PET/CT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2018
Last Updated
February 20, 2023
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT03442504
Brief Title
Prediction of Response to 2nd-line Hormone Therapy by FES CT/PET in Patients With Metastatic Breast Cancer
Acronym
TEP-FES
Official Title
Evaluation Study of the Prediction of the Response to Second-line Hormone Therapy by 16α- [18F] Fluoro-17β-estradiol (FES) PET in Patients With Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
January 11, 2023 (Actual)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Approximately 70% of breast cancer patients have estrogen-receptor-expressing tumors, making hormone therapy an attractive option for adjuvant and metastatic treatment. The expression of estrogen receptors is modified during the course of treatment. Tumor development, there is a discrepancy between primary tumors and metastases from 14.5% to 40% of cases. Biopsies are useful for reassessing a patient's "estrogen receptor" status, but it is not always feasible especially at the stage of multiple metastases and the gesture remains invasive. The sensitivity and specificity of PET FES has been studied in patients with "estrogen-positive receptor" breast cancer lesions. Sensitivity was good except for liver metastases due to physiological binding of this tracer to the liver. Quantification of FES binding was correlated with expression of estrogen receptors visualized in IHC. Metastases could be seen with FES in the bone, lung and lymph nodes and more difficult in the liver. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
metastatic Breast cancer, FES PET/CT, menopausal patients, recurrence after a 1st line of hormone therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES PET/CT
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
FES PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine the predictive value of PET at the "lesion" level
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Determine the predictive value of PET at FES at the "patient" level
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline ROUSSEAU, MD
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancerologie de l'Ouest
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
CHU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
ICO René Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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