Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer

Metastatic Breast Cancer Clinical Trial

— ESTROTEPREDIC  

Official title:

16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627704
• Other study ID #: P110113
• Secondary ID: IDRCB
• Status: Completed
• Phase: N/A
• First received: June 14, 2012
• Last updated: October 13, 2015
• Start date: June 2012
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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• Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Fluoroestradiol (18F)
2-4 MBq/kg body mass, one single IV injection

Locations

Country	Name	City	State
France	Service de Médecine Nucléaire, Hôpital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate six months after induction or major change in hormone therapy for metastatic breast cancer.	Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. Response will be determined according to RECIST 1.1 criteria for each patient.	at 6 months	No
Secondary	Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers.		at 6 months	Yes