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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline
* Procedure: Diagnostic Imaging: 18F-FES PET/CT - Baseline
* Procedure: Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/CT Guided FES Therapy<br>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 - Baseline<br>* A18F-FDG PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to identify the sites involved by the subject's cancer.<br>Procedure: Diagnostic Imaging: 18F-FES PET/CT - Baseline<br>* 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.<br>Procedure: Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up<br>* A 18F-FES PET/CT scan performed after three (3) monthly injections of fulvestrant to determine whether estrogen uptake is blocked by fulvestrant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-menopausal hormone receptor positive recurrent/metastatic breast cancer., PET/CT, Recurrent or metastatic