- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00816582
PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
A Phase II Clinical Trial to Evaluate 18F-Fluoroestradiol Positron Emission Tomography / Computerized Tomography (PET/CT) Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
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.
Study Overview
Status
Conditions
Detailed Description
The majority of women diagnosed with breast cancer are post-menopausal, of which up to 75% are estrogen (ER) and/or progesterone receptor (PR) positive. Even in pre-menopausal breast cancer over half of all patients will have expression of these hormone receptors. Thus therapeutic strategies targeting the estrogen receptor or its ligand are the most common treatment offered in breast cancer. Despite substantial benefits now demonstrated with selective estrogen receptor modulators (e.g. tamoxifen) and aromatase inhibitors (e.g. anastrazole, letrozole and exemestane), a significant proportion of patients will still unfortunately have or develop resistance to these hormonal therapies.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- BC Cancer Agency - Southern Interior
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Surrey, British Columbia, Canada, V3V 1Z2
- BC Cancer Agency - Fraser Valley
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency - Vancouver Centre
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Victoria, British Columbia, Canada, V8R 6V5
- BC Cancer Agency - Vancouver Island
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- life threatening metastatic visceral disease
- brain or leptomeningeal metastases
- prior exposure to fulvestrant
- history of bleeding diathesis or need for long term anti-coagulation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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A18F-FDG PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to identify the sites involved by the subject's cancer.
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.
A 18F-FES PET/CT scan performed after three (3) monthly injections of fulvestrant to determine whether estrogen uptake is blocked by fulvestrant.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Benefit Rate (CBR)
Time Frame: 24 weeks
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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.
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24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen Chia, MD, BC Cancer Agency - Vancouver Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PET/CT Breast
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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