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

NCT01627704 | Completed

• 2 other identifiers: P110113IDRCB
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

PET/CT,fluoroestradiol (18F); breast cancer; metastatic; prediction of response; hormone therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

Fluoroestradiol (18F)

OTHER

Drug: Fluoroestradiol (18F)

Interventions

Fluoroestradiol (18F) DRUG

2-4 MBq/kg body mass, one single IV injection

Fluoroestradiol (18F)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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• Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Nucléaire, Hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Khaldoun KERROU, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 26, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

FR (1)