PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00816582|
Recruitment Status : Active, not recruiting
First Posted : January 1, 2009
Last Update Posted : December 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||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||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 2010|
|Actual Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2020|
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.
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.
- Clinical Benefit Rate (CBR) [ Time Frame: 24 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816582
|Canada, British Columbia|
|BC Cancer Agency - Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BC Cancer Agency - Fraser Valley|
|Surrey, British Columbia, Canada, V3V 1Z2|
|BC Cancer Agency - Vancouver Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|BC Cancer Agency - Vancouver Island|
|Victoria, British Columbia, Canada, V8R 6V5|
|Principal Investigator:||Stephen Chia, MD||BC Cancer Agency - Vancouver Centre|