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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01627704
First received: June 14, 2012
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Metastatic Breast Cancer
Drug: Fluoroestradiol (18F)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers. [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fluoroestradiol (18F)
NA
Drug: Fluoroestradiol (18F)
2-4 MBq/kg body mass, one single IV injection

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627704

Contacts
Contact: Khaldoun KERROU, MD 33 1 56 01 67 98 Khaldoun.kerrou@tnn.aphp.fr
Contact: Jean-Noël TALBOT, MD-PHD Jean-noel.talbot@tnn.aphp.fr

Locations
France
Service de Médecine Nucléaire, Hôpital Tenon Recruiting
Paris, France, 75020
Contact: Khaldoun KERROU, MD    33 1 56 01 67 98    Khaldoun.kerrou@tnn.aphp.fr   
Contact: Jean-Noël TALBOT, MD, PhD       Jean-noel.talbot@tnn.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Khaldoun KERROU, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01627704     History of Changes
Other Study ID Numbers: P110113, IDRCB
Study First Received: June 14, 2012
Last Updated: September 6, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
PET/CT,fluoroestradiol (18F)
breast cancer
metastatic
prediction of response
hormone therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014