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PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer

NCT00816582 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-11-16

No results posted yet for this study

Summary

Purpose:

To determine whether \[18F\]FES can predict clinical benefit (defined as complete response, partial response and stable disease ≥ 6 months) to fulvestrant (250 mg IM q 28 days) in post-menopausal women with recurrent or metastatic ER+ breast cancer who are candidates for further hormonal therapy.

Conditions

Interventions

PROCEDURE

Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline

A18F-FDG PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to identify the sites involved by the subject's cancer.

PROCEDURE

Diagnostic Imaging: 18F-FES PET/CT - Baseline

A 18F-FES PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to determine the hormone receptor content of the sites involved by the breast cancer.

PROCEDURE

Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up

A 18F-FES PET/CT scan performed after three (3) monthly injections of fulvestrant to determine whether estrogen uptake is blocked by fulvestrant.

Sponsors & Collaborators

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Stephen Chia, MD · BC Cancer Agency - Vancouver Centre

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-09-17
Completion
2018-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00816582 on ClinicalTrials.gov