PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
NCT ID: NCT00816582
Last Updated: 2021-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
17 participants
INTERVENTIONAL
2010-11-30
2018-07-31
Brief Summary
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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.
Detailed Description
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Despite approximately two-thirds of patients who are prescribed fulvestrant following prior hormonal agents not benefiting from this therapy, clinicians are still offering this option to all suitable women because of the lack of a better means of identifying the individual responders.
To assess whether the recommended treatment is beneficial to a specific individual, the disease burden is assessed before and following treatment. Conventional imaging techniques such as the bone scan or computerized tomography (CT) can take several months to show a successful response to treatment. Positron emission tomography (PET) can improve the evaluation of women with breast cancer by providing an accurate assessment of the extent of disease and unique information about tumor biology such as metabolic activity.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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PET/CT Guided FES Therapy
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* brain or leptomeningeal metastases
* prior exposure to fulvestrant
* history of bleeding diathesis or need for long term anti-coagulation
45 Years
FEMALE
No
Sponsors
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British Columbia Cancer Agency
OTHER
Responsible Party
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Principal Investigators
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Stephen Chia, MD
Role: PRINCIPAL_INVESTIGATOR
BC Cancer Agency - Vancouver Centre
Locations
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BC Cancer Agency - Southern Interior
Kelowna, British Columbia, Canada
BC Cancer Agency - Fraser Valley
Surrey, British Columbia, Canada
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
BC Cancer Agency - Vancouver Island
Victoria, British Columbia, Canada
Countries
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Other Identifiers
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PET/CT Breast
Identifier Type: -
Identifier Source: org_study_id