Breast CancerNCT00816582
PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
A study testing Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline, Diagnostic Imaging: 18F-FES PET/CT - Baseline and Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up in people with Breast Cancer, run by British Columbia Cancer Agency at 4 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline, Diagnostic Imaging: 18F-FES PET/CT - Baseline and Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesCanada
- Study dates
- 30 Nov 2010to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- life threatening metastatic visceral disease
- brain or leptomeningeal metastases
- prior exposure to fulvestrant
- history of bleeding diathesis or need for long term anti-coagulation
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
BC Cancer Agency - Southern Interior
Kelowna, British Columbia, V1Y 5L3
BC Cancer Agency - Fraser Valley
Surrey, British Columbia, V3V 1Z2
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
BC Cancer Agency - Vancouver Island
Victoria, British Columbia, V8R 6V5
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline, Diagnostic Imaging: 18F-FES PET/CT - Baseline, Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up
- Keywords
- Post-menopausal hormone receptor positive recurrent/metastatic breast cancer., PET/CT, Recurrent or metastatic
- Medical subject headings
- Breast Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Imaging: 18F-FDG PET/CT Scan - BaselineProcedure or surgery
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 - BaselineProcedure or surgery
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-upProcedure or surgery
A 18F-FES PET/CT scan performed after three (3) monthly injections of fulvestrant to determine whether estrogen uptake is blocked by fulvestrant.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT Guided FES Therapy | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study start30 Nov 2010
- Primary completion17 Sep 2014
- Study completionJul 2018
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Chia, MD, Principal investigator, BC Cancer Agency - Vancouver Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816582
- Sponsor's protocol ID
- PET/CT Breast
- Status last verified
- Nov 2021
- First submitted
- 30 Dec 2008
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00816582
- Acronym / sponsor ID
- PET/CT Breast
- Conditions
- Breast Cancer
- Keywords
- Post-menopausal hormone receptor positive recurrent/metastatic breast cancer., PET/CT, Recurrent or metastatic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 17 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 30 Nov 2010 (actual)
- Primary completion
- 17 Sep 2014 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 1 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT Guided FES Therapy | Experimental | 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-upAll 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- life threatening metastatic visceral disease
- brain or leptomeningeal metastases
- prior exposure to fulvestrant
- history of bleeding diathesis or need for long term anti-coagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Imaging: 18F-FDG PET/CT Scan - BaselineA18F-FDG PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to identify the sites involved by the subject's cancer. | Procedure or surgery | PET/CT Guided FES Therapy |
| Diagnostic Imaging: 18F-FES PET/CT - BaselineA 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 or surgery | PET/CT Guided FES Therapy |
| Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-upA 18F-FES PET/CT scan performed after three (3) monthly injections of fulvestrant to determine whether estrogen uptake is blocked by fulvestrant. | Procedure or surgery | PET/CT Guided FES Therapy |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Chia, MD principal investigator
BC Cancer Agency - Vancouver Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline, Diagnostic Imaging: 18F-FES PET/CT - Baseline and Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up in people with Breast Cancer, run by British Columbia Cancer Agency at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate (CBR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.