NCT00816582

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2009

Completed
1.9 years until next milestone

Study Start

First participant enrolled

November 30, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2014

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

3.8 years

First QC Date

December 30, 2008

Last Update Submit

November 15, 2021

Conditions

Breast Cancer

Keywords

Post-menopausal hormone receptor positive recurrent/metastatic breast cancer.PET/CTRecurrent or metastatic

Outcome Measures

Primary Outcomes (1)

  • Clinical Benefit Rate (CBR)

    CBR is defined as a patient having a best overall response of a complete response (CR), partial response (PR), or stable disease for at least 24 weeks.

    24 weeks

Study Arms (1)

PET/CT Guided FES Therapy

EXPERIMENTAL

All subjects will be seen at baseline and then monthly until month 6 of fulvestrant therapy unless clinical or radiological progression or unacceptable toxicity earlier than month 6.

Procedure: Diagnostic Imaging: 18F-FDG PET/CT Scan - BaselineProcedure: Diagnostic Imaging: 18F-FES PET/CT - BaselineProcedure: Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up

Interventions

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

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

PET/CT Guided FES Therapy
Diagnostic Imaging: 18F-FES PET/CT - BaselinePROCEDURE

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.

PET/CT Guided FES Therapy
Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-upPROCEDURE

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

PET/CT Guided FES Therapy

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post-menopausal (≥ 60 years old, or age ≥ 45 years with amenorrhea for \> 12 months or follicle stimulating hormone and estrogen levels within post-menopausal range, or prior bilateral oophorectomy)
  • hormone receptor positive (ER and/or PgR) disease as determined locally
  • WHO performance status 0-2
  • life expectancy of ≥ 3 months
  • the presence of at least one measurable or evaluable (non-measurable) lesion
  • informed consent prior to any study procedures

You may not qualify if:

  • life threatening metastatic visceral disease
  • brain or leptomeningeal metastases
  • prior exposure to fulvestrant
  • history of bleeding diathesis or need for long term anti-coagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

BC Cancer Agency - Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BC Cancer Agency - Fraser Valley

Surrey, British Columbia, V3V 1Z2, Canada

Location

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BC Cancer Agency - Vancouver Island

Victoria, British Columbia, V8R 6V5, Canada

Location

MeSH Terms

Conditions

Breast NeoplasmsRecurrenceNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Study Officials

  • Stephen Chia, MD

    BC Cancer Agency - Vancouver Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 30, 2008

First Posted

January 1, 2009

Study Start

November 30, 2010

Primary Completion

September 17, 2014

Study Completion

July 1, 2018

Last Updated

November 16, 2021

Record last verified: 2021-11

Locations

CA(4)