Breast CancerPhase 2NCT02455453

Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography

A Phase 2 study testing 18F-FFNP, CTI/Siemens Biograph 40 PET/CT Scanner and Estradiol in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: 18F-FFNP, CTI/Siemens Biograph 40 PET/CT Scanner and Estradiol
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited States
Study dates: 28 Apr 2015to 3 Jan 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patient must be postmenopausal defined as meeting one or more of the following:
Age ≥ 60 years
Amenorrheic for at least 12 months
Surgically sterile- having undergone bilateral oophorectomy,
FSH level in postmenopausal range according to institutional standards (note follicle-stimulating hormone (FSH) laboratory testing must be ordered as standard of care to determine optimal treatment and should not be ordered simply to confirm eligibility to this study)
OR Pre-menopausal for whom standard estradiol treatment (ET) is planned with ovarian suppression (imaging on study should be completed prior to start of ovarian suppression)

Show all 20Show fewer

Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:
New diagnosis with plans for at least 6 months of neoadjuvant ET or any amount of neoadjuvant ET if surgery is planned as this will be used for response assessment .
Patients with newly diagnosed metastatic breast cancer or patient with known metastatic disease who has progressed while on therapy (no washout period is needed if the patient was treated with AIs or chemotherapy, but 2 months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET.
Patient must have any one of the following types of breast cancer (primary or metastatic): ER+/PgR+/HER2- or ER+/PgR-/HER2-.
ER+ is defined as Allred score of at least 4 and greater.
PgR+ is defined as Allred score of at least 4 and greater.
Immunohistochemistry (IHC) is the primary assay methodology for HER2. HER2- refers to HER2 of 0, 1+ by IHC or negative by fluorescence in situ hybridization (FISH)
Patient must have at least one measurable lesion according to RECIST 1.1 by radiological evaluation (ultrasound, mammography, MRI, CT, PET) or physical examination.
Patients with evaluable osseous metastasis that are lytic or mixed lytic-sclerotic are eligible.
Patients with hepatic lesions may be eligible provided the location of the lesion is peripheral or not too close to hepatic ducts. Decision on hepatic lesion eligibility will be made by the principal investigator or sub-investigator after careful review of all available imaging to ensure evaluation of the lesion will not be obscured by normal hepatobiliary excretion of 18F-FFNP.
Patient must be able to understand and willing to sign a written informed consent document.
Prior chemotherapy or endocrine therapy is allowed
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or, based on the judgment of the treating medical oncologist, can tolerate imaging and at least 6 months of ET
The patient should have a life expectancy of > 6 months.

Who cannot join

Patient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 years
Unable to tolerate up to 60 min of PET imaging per imaging session.
Patients with non-measurable non-evaluable lesions such as pleural effusion are not eligible to participate.
Patients with vertebral lesions that, in the opinion of the Principal Investigator and the treating medical oncologist, pose an imminent risk for cord compression.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

The purpose of this study is to evaluate the uptake of a radioactive tracer 21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione (FFNP) uptake, which binds to breast cancer progesterone receptors (PgRs) on a PET/CT scan before and after administration of estradiol for one day (estrogen challenge) to determine if the change in uptake is a predictor of response to endocrine therapy (ET) in patients with hormone-sensitive estrogen receptor positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Estradiol is the most potent of the naturally occurring estrogens, and can be administered to treat menopausal symptoms and also sometimes to treat metastatic breast cancer. The investigators propose to study patients with biopsy-proven newly diagnosed, locally advanced, metastatic, or recurrent breast cancer who are going to be treated with endocrine therapy (ET) (tamoxifen,aromatase inhibitors or fulvestrant as standard of care therapy.

Subjects will undergo a total of two FFNP-PET/CT scans; one before and a second one immediately following the one day estradiol challenge before the start of standard of care ET. The estradiol challenge will consist of administering a total of 6 mg of estradiol orally (three doses of 2 mg each) given at approximately 8 hour intervals and over a 24 hour period.

Conditions: Breast Cancer
Being tested: 18F-FFNP, CTI/Siemens Biograph 40 PET/CT Scanner, Estradiol, 18F-FDG
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

18F-FFNPDrug
Also called 21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione
CTI/Siemens Biograph 40 PET/CT ScannerDevice
- Will include (1) 18-FDG-PET/CT scan
- Will include (2) 18F-FFNP-PET/CT scans
EstradiolDrug
18F-FDGDrug

Study groups in NCT02455453
Study group	Role	What they receive
Diagnostic FFNP-PET/CT Scan	Experimental	* (2) 18F-FFNP-PET/CT scans * First one prior to estradiol challenge test * Second one immediately following one day of estradiol challenge test * (1) FDG-PET/CT scan at screening * The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study. Receives: Drug: 18F-FFNP; Device: CTI/Siemens Biograph 40 PET/CT Scanner; Drug: Estradiol; Drug: 18F-FDG

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Primary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)
Measured: Completion of second FFNP-PET/CT scan (up to 4 weeks)
Change in Secondary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)
Measured: Completion of second FFNP-PET/CT scan (up to 4 weeks)

Secondary outcomes (1)

Heterogeneity of Tumor FFNP Uptake as Measured by Number of Participants With Heterogenous Response
As measured visually in known lesion by recording presence or absence of uptake with note of any changes between scans
Measured: Completion of second FFNP-PET/CT scan (up to 4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Apr 20153 Jan 2019

First posted27 May 2015 (estimated)
Study start28 Apr 2015
Primary completion3 Jan 2019
Study completion3 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02455453
Sponsor's protocol ID: 201411005
Other IDs: 5R01CA195450-03
Status last verified: Jan 2020
First submitted: 14 May 2015
Last updated: 14 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Dehdashti F, Wu N, Ma CX, Naughton MJ, Katzenellenbogen JA, Siegel BA. Association of PET-based estradiol-challenge test for breast cancer progesterone receptors with response to endocrine therapy. Nat Commun. 2021 Feb 2;12(1):733. doi: 10.1038/s41467-020-20814-9.
PubMed 33531464

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography
ClinicalTrials.gov ID: NCT02455453
Acronym / sponsor ID: 201411005
Conditions: Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 28 Apr 2015 (actual)
Primary completion: 3 Jan 2019 (actual)
Study completion: 3 Jan 2019 (actual)
First posted: 27 May 2015 (estimated)
Results: Posted 14 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic FFNP-PET/CT Scan	Experimental	Drug: 18F-FFNP, Device: CTI/Siemens Biograph 40 PET/CT Scanner, Drug: Estradiol, Drug: 18F-FDG* (2) 18F-FFNP-PET/CT scans * First one prior to estradiol challenge test * Second one immediately following one day of estradiol challenge test * (1) FDG-PET/CT scan at screening * The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Patient must be postmenopausal defined as meeting one or more of the following:
Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:
Patient must have any one of the following types of breast cancer (primary or metastatic): ER+/PgR+/HER2- or ER+/PgR-/HER2-.
Patient must have at least one measurable lesion according to RECIST 1.1 by radiological evaluation (ultrasound, mammography, MRI, CT, PET) or physical examination.
Patient must be able to understand and willing to sign a written informed consent document.

Key exclusion criteria (4 listed)

Patient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 years
Unable to tolerate up to 60 min of PET imaging per imaging session.
Patients with non-measurable non-evaluable lesions such as pleural effusion are not eligible to participate.
Patients with vertebral lesions that, in the opinion of the Principal Investigator and the treating medical oncologist, pose an imminent risk for cord compression.

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
18F-FFNPAlso: 21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione	Drug	Diagnostic FFNP-PET/CT Scan
CTI/Siemens Biograph 40 PET/CT Scanner* Will include (1) 18-FDG-PET/CT scan * Will include (2) 18F-FFNP-PET/CT scans	Device	Diagnostic FFNP-PET/CT Scan
Estradiol	Drug	Diagnostic FFNP-PET/CT Scan
18F-FDG	Drug	Diagnostic FFNP-PET/CT Scan

Primary outcome

Change in Primary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)
Time frame: Completion of second FFNP-PET/CT scan (up to 4 weeks)
Change in Secondary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)
Time frame: Completion of second FFNP-PET/CT scan (up to 4 weeks)

1 secondary outcome

Heterogeneity of Tumor FFNP Uptake as Measured by Number of Participants With Heterogenous Response
Time frame: Completion of second FFNP-PET/CT scan (up to 4 weeks)

Results and safety

Results posted to the registry on 14 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic FFNP-PET/CT Scan	47	47

Primary outcome: Change in Primary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)

Time frame: Completion of second FFNP-PET/CT scan (up to 4 weeks). Median (Full Range). Unit: percent change in SUV

Measure	Diagnostic FFNP-PET/CT Scan n = 45
Value	11.0 (-46.0 to 306.0)

Population analysed: 2 participants were not included in this outcome measure as the liver background was too high in both participants.

Primary outcome: Change in Secondary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)

Time frame: Completion of second FFNP-PET/CT scan (up to 4 weeks). Median (Full Range). Unit: percent change in SUV

Measure	Diagnostic FFNP-PET/CT Scan n = 33
Value	15.0 (-48.0 to 306.0)

Population analysed: 12 participants were not included in this outcome measure as they did not have a secondary tumor location and 2 participants were not included in this outcome measure as the liver background was too high in both participants.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic FFNP-PET/CT Scan	0 of 47 (0%)	11 of 47 (23.4%)	5 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33531464Dehdashti F, Wu N, Ma CX, Naughton MJ, Katzenellenbogen JA, Siegel BA. Association of PET-based estradiol-challenge test for breast cancer progesterone receptors with response to endocrine therapy. Nat Commun. 2021 Feb 2;12(1):733. doi: 10.1038/s41467-020-20814-9.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

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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 University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18F-FFNP, CTI/Siemens Biograph 40 PET/CT Scanner and Estradiol 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 20 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: finished, as of the sponsor's last update on 14 Jan 2020. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Primary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV) (time frame: Completion of second FFNP-PET/CT scan (up to 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02455453, which also lists 1 linked publication.

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 14 Jan 2020.