Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

Thank you

Trial Information

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


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


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- Treated by antihormone treatment during around 5 years withdrawn for at least 3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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate six months after induction or major change in hormone therapy for metastatic breast cancer.

Outcome Description:

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.

Outcome Time Frame:

at 6 months

Safety Issue:

No

Principal Investigator

Khaldoun KERROU, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P110113

NCT ID:

NCT01627704

Start Date:

June 2012

Completion Date:

June 2015

Related Keywords:

  • Metastatic Breast Cancer
  • PET/CT,fluoroestradiol (18F)
  • breast cancer
  • metastatic
  • prediction of response
  • hormone therapy
  • Breast Neoplasms

Name

Location