PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
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 Design:||Intervention Model: Single Group Assignment
Masking: 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|
- Clinical Benefit Rate (CBR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
Procedure: PET/CT Scan
- 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.
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.
During the study the subject will undergo the following scans:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816582
|Contact: Stephen Chia, MD||604-877-6000 ext firstname.lastname@example.org|
|Contact: Francois Benard, MD||604-877-6000 ext email@example.com|
|Canada, British Columbia|
|BC Cancer Agency - Southern Interior||Recruiting|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|Contact: Susan Ellard, MD 250-712-3996 firstname.lastname@example.org|
|Principal Investigator: Susan Ellard, MD|
|Sub-Investigator: Marianne Taylor, MD|
|Sub-Investigator: Barbara Czerkawski, MD|
|BC Cancer Agency - Fraser Valley||Recruiting|
|Surrey, British Columbia, Canada, V3V 1Z2|
|Contact: Gary Pansegrau, MD 604-930-4017 email@example.com|
|Principal Investigator: Gary Pansegrau, MD|
|Sub-Investigator: Abdulwahab Al-Tourah, MD|
|Sub-Investigator: Ravinder Sawhney, MD|
|BC Cancer Agency - Vancouver Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Contact: Stephen Chia, MD 604-877-6000 ext 2752 firstname.lastname@example.org|
|Contact: Francois Benard, MD 604-877-6000 ext 5979 email@example.com|
|Principal Investigator: Stephen Chia, MD|
|Sub-Investigator: Caroline Lohrisch, MD|
|Sub-Investigator: Cheryl Ho, MD|
|Sub-Investigator: Karen Gelmon, MD|
|Sub-Investigator: Don Wilson, MD|
|BC Cancer Agency - Vancouver Island||Recruiting|
|Victoria, British Columbia, Canada, V8R 6V5|
|Contact: Nicol Macpherson, MD 250-519-5572 firstname.lastname@example.org|
|Sub-Investigator: Vanessa Bernstein, MD|
|Principal Investigator: Nicol Macpherson, MD|
|Sub-Investigator: Sheila Souliere, MD|
|Sub-Investigator: Andrew Attwell, MD|
|Sub-Investigator: Sharon Allan, MD|
|Sub-Investigator: Jason Hart, MD|
|Principal Investigator:||Stephen Chia, MD||BC Cancer Agency - Vancouver Centre|