Clinical trial NCT03442504: Prediction of Response to 2nd-line Hormone Therapy by FES CT/PET in Patients With Metastatic Breast Cancer
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: metastatic Breast cancer
FES PET/CT
menopausal patients
recurrence after a 1st line of hormone therapy
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the predictive value of PET at the "lesion" level
timeFrame: 6 weeks
Secondary outcomes:
measure: Determine the predictive value of PET at FES at the "patient" level
timeFrame: 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de l'Ouest
city: Brest
country: France
facility: CHU de Brest
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Saint-Herblain
country: France
facility: ICO René Gauducheau
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Caroline ROUSSEAU, MD
role: PRINCIPAL_INVESTIGATOR
References: