Breast CancerNCT01714128
FES-PET for Patients Treated on NCI Protocol 8762
A study testing Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES)) in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
A significant number of all invasive breast cancers are hormone sensitive and may be candidates for treatment with hormonal therapy. This project will assess the ability and usefulness of imaging hormone-receptor status in breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol (FES), an… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2015
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have agreed and signed consent to participate in NCI protocol 8762 and be scheduled to receive the first dose of MK-2206 in a minimum of 48 hours and a maximum of 30 days after the FES-PET/CT imaging.
- Note: Patients need to be on the endocrine agent for at least 1 week prior to the FES-PET/CT imaging.
- Patients must have measurable disease (defined by RECIST criteria) or the presence of bone lesions if there is no measurable lesion.
- Patient must be ≥ 18 years of age.
- Patient must be able to tolerate and have no contraindication to FES-PET/CT imaging.
- Patient must be able and willing to give informed consent.
Who cannot join
- Patient must have no other active cancer at the time of study entry.
- The research FES-PET/CT scan could not be scheduled more than 48 hours before starting therapy with MK-2206.
- Patient cannot have received treatment for any other malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
- Patients scheduled to receive chemotherapy as the primary source of treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Mallinckrodt Institute of Radiology
St Louis, Missouri, 63110
About this study
Official title: Positron Emission Tomography (PET) With 18F-Fluoroestradiol (FES) as a Predictor of Response in Patients With Breast Cancer Scheduled to be Treated With MK-2206 in Combination With Either an Aromatase Inhibitor or Fulvestrant on NCI Protocol 8762
A significant number of all invasive breast cancers are hormone sensitive and may be candidates for treatment with hormonal therapy.
This project will assess the ability and usefulness of imaging hormone-receptor status in breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol (FES), an estrogen analogue in patients who are scheduled to be treated with hormonal therapy given in combination with a selective allosteric inhibitor of AKT protein kinase (MK2206) .
Read the detailed description
Approximately 75% of all invasive breast cancers are hormone sensitive [estrogen-receptor positive (ER+) or progesterone-receptor positive (PR+)] and patients with such cancers are candidates for endocrine therapy. Endocrine therapy is a central component of the treatment of hormone-sensitive breast cancer in the adjuvant and, increasingly, neoadjuvant settings. Knowledge of hormone receptor expression is essential for selection of appropriate therapy. Measurement of hormone-receptor expression [estrogen receptor (ER) or progesterone receptor (PR)] using in vitro assays of the tumor tissue at the time of primary diagnosis is standard of clinical care. However, the presence of these hormone receptors predicts for clinical benefit in only 30-50% of women with advanced disease receiving first-line endocrine therapy and 15-30% receiving second-line therapy (1-3). Thus, the presence of a hormone receptor does not indicate that the receptor is functional and essential to the growth of the cancer cell, nor does it imply that interference with receptor function will result in tumor cell kill. There are several shortcomings of the in vitro assays and neither quantitative nor qualitative receptor assays performed on samples of tumor tissue completely predict the response to antiestrogen therapy in breast cancers. In addition, none of the current clinical tools (serologies, prognostic factors, or radiologic studies) can accurately predict for clinical benefit from endocrine therapy. Accordingly, better methods for predicting clinical response to antiestrogen therapy need to be developed.
- Conditions
- Breast Cancer
- Being tested
- Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))
- Keywords
- NCI protocol #8762, Estrogen receptor positive breast cancer, recurrent breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))Drug
FES-PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Optional Diagnostic Imaging | Other | Optional diagnostic imaging FES-PET/CT imaging Receives: Drug: Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FES baseline tumor SUV measurement
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startJun 2013
- Primary completionJan 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Study Funding no longer available
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 Washington University School of MedicineThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farrokh Dehdashti, Washington University School of Medicine
- Investigators
- Farrokh Dehdashti, M.D., Principal investigator, Washington Univesity in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714128
- Sponsor's protocol ID
- Dehdashti FES NCI#9167
- Status last verified
- Oct 2021
- First submitted
- 17 Oct 2012
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography (PET) With 18F-Fluoroestradiol (FES) as a Predictor of Response in Patients With Breast Cancer Scheduled to be Treated With MK-2206 in Combination With Either an Aromatase Inhibitor or Fulvestrant on NCI Protocol 8762
- ClinicalTrials.gov ID
- NCT01714128
- Acronym / sponsor ID
- Dehdashti FES NCI#9167
- Conditions
- Breast Cancer
- Keywords
- NCI protocol #8762, Estrogen receptor positive breast cancer, recurrent breast cancer, stage IV breast cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Funding no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Oct 2012 (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.
A significant number of all invasive breast cancers are hormone sensitive and may be candidates for treatment with hormonal therapy.
This project will assess the ability and usefulness of imaging hormone-receptor status in breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol (FES), an estrogen analogue in patients who are scheduled to be treated with hormonal therapy given in combination with a selective allosteric inhibitor of AKT protein kinase (MK2206) .
Detailed description
Approximately 75% of all invasive breast cancers are hormone sensitive [estrogen-receptor positive (ER+) or progesterone-receptor positive (PR+)] and patients with such cancers are candidates for endocrine therapy. Endocrine therapy is a central component of the treatment of hormone-sensitive breast cancer in the adjuvant and, increasingly, neoadjuvant settings. Knowledge of hormone receptor expression is essential for selection of appropriate therapy. Measurement of hormone-receptor expression [estrogen receptor (ER) or progesterone receptor (PR)] using in vitro assays of the tumor tissue at the time of primary diagnosis is standard of clinical care. However, the presence of these hormone receptors predicts for clinical benefit in only 30-50% of women with advanced disease receiving first-line endocrine therapy and 15-30% receiving second-line therapy (1-3). Thus, the presence of a hormone receptor does not indicate that the receptor is functional and essential to the growth of the cancer cell, nor does it imply that interference with receptor function will result in tumor cell kill. There are several shortcomings of the in vitro assays and neither quantitative nor qualitative receptor assays performed on samples of tumor tissue completely predict the response to antiestrogen therapy in breast cancers. In addition, none of the current clinical tools (serologies, prognostic factors, or radiologic studies) can accurately predict for clinical benefit from endocrine therapy. Accordingly, better methods for predicting clinical response to antiestrogen therapy need to be developed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optional Diagnostic Imaging | Other | Drug: Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))Optional diagnostic imaging FES-PET/CT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have agreed and signed consent to participate in NCI protocol 8762 and be scheduled to receive the first dose of MK-2206 in a minimum of 48 hours and a maximum of 30 days after the FES-PET/CT imaging.
- Note: Patients need to be on the endocrine agent for at least 1 week prior to the FES-PET/CT imaging.
- Patients must have measurable disease (defined by RECIST criteria) or the presence of bone lesions if there is no measurable lesion.
- Patient must be ≥ 18 years of age.
- Patient must be able to tolerate and have no contraindication to FES-PET/CT imaging.
Key exclusion criteria (4 listed)
- Patient must have no other active cancer at the time of study entry.
- The research FES-PET/CT scan could not be scheduled more than 48 hours before starting therapy with MK-2206.
- Patient cannot have received treatment for any other malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
- Patients scheduled to receive chemotherapy as the primary source of treatment
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 ( 6α-[18F]fluoro-17β-estradiol (FES))FES-PET/CT imaging | Drug | Optional Diagnostic Imaging |
Primary outcome
FES baseline tumor SUV measurement
Time frame: Up to 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 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.
Farrokh Dehdashti, M.D. principal investigator
Washington Univesity in St. Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES)) in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 withdrawn before enrolling participants, so there are no results.
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?
FES baseline tumor SUV measurement (time frame: Up to 36 months). 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 25 Oct 2021.