Clinical trial NCT01627704: Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer
Official title: 16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: PET/CT,fluoroestradiol (18F)
breast cancer
metastatic
prediction of response
hormone therapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.

Detailed description: Main objective: Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline.

Secondary objectives:

* evaluate diagnostic performance of FES PET/CT
* determine whether FES PET/CT is able to detect metastases that are not visible on FDG PET/CT. This point may constitute a direct benefit for the patient
* precise the nature of discordant FES/FDG foci
* validate and improve the interpretation criteria for FES PET/CT
* confirm the perfect tolerance

Eligibility criteria: Inclusion Criteria:

* Post menopausal
* age \> 17
* WHO 0-2
* Metastatic adenocarcinoma of the breast
* Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment
* Life expectancy \> 6 months
* Hormone-dependent cancer initially demonstrated by hormone receptors in the tumour
* Presence of oestrogen receptors proven with immunohistochemistry (\> 10%) and HER2 determined by immunohistochemistry or FISH (on primary tumour or a metastasis)
* Metastatic recurrence on FDG PET dating less than 1 month, confirmed by another modality (contrast-enhanced CT, MRI, ultrasonography, bone scintigraphy or PET/CT, other)
* FDG PET/CT available on PACS or CD DICOM III format 11
* Informed consent obtained

Exclusion Criteria:

* Other evolutive malignant disease or acute or chronic infectious disease
* Chemotherapy during the last 3 months or change in treatment since FDG PET/CT.
* Isolated liver metastasis (high FES uptake by normal liver)

Primary outcomes:
measure: Response rate six months after induction or major change in hormone therapy for metastatic breast cancer.
timeFrame: at 6 months
Secondary outcomes:
measure: Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers.
timeFrame: at 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Médecine Nucléaire, Hôpital Tenon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Khaldoun KERROU, MD
role: PRINCIPAL_INVESTIGATOR
References: