Metastatic CancerPhase 2NCT06067503
Biomarkers to Detect Endocrine Therapy Resistance
A Phase 2 study testing 18F-fluorofuranylnorprogesterone, Liquid Biopsy and Positron Emission Tomography/Computed Tomography in people with Metastatic Cancer and Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This pilot observational study is being done to identify possible biomarkers of response to endocrine therapy in patients with ER/PR+ metastatic lobular breast cancer (LBC) starting new endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Breast Cancer, Lobular Breast Carcinoma
- What is being tested?
- 18F-fluorofuranylnorprogesterone, Liquid Biopsy and Positron Emission Tomography/Computed Tomography
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide informed consent
- Individuals at least 18 years of age
- Have biopsy-proven ER/PR-positive (defined as ER ≥1 percent and PR ≥1 percent by IHC) and HER2-negative advanced or metastatic LBC starting new standard of care endocrine therapy
- Adequate organ function as indicated by standard laboratory tests (CBC, liver function tests or CMP) allowing for systemic breast cancer treatment per treating oncologist
- Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible
- Willing to comply with all study procedures and be available for the duration of the study
- Disease may be measurable by RECIST 1.1 criteria or non-measurable. Lesion size must be at least 1cm. If only bone lesions present, they should be lytic or mixed lytic-sclerotic. If only liver lesions present, patient is not eligible.
Who cannot join
- Patients with active brain metastases
- Patients with liver-only disease are not eligible due to high background liver activity related to the radiopharmaceutical's hepatobiliary route of elimination
- Unable to lie flat during or tolerate PET/CT
- Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
- Presence of liver failure as judged by patient's treating physician
- Individuals who are pregnant, lactating, or planning on becoming pregnant during the study
- Not suitable for study participation due to other reasons at the discretion of the investigators
- Patients with progesterone-receptor negative disease defined as PR <1 percent by IHC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer
This pilot observational study is being done to identify possible biomarkers of response to endocrine therapy in patients with ER/PR+ metastatic lobular breast cancer (LBC) starting new endocrine therapy. 18F-fluorofuranylnorprogesterone Positron Emission Tomography/Computed Tomography (FFNP-PET/CT) and liquid biopsies will be performed at baseline and after 4 weeks of treatment. Baseline levels and dynamic on-treatment changes in estrogen signaling as measured by FFNP-PET/CT and circulating tumor cell (CTC) liquid biopsy will be correlated with clinical response to endocrine therapy and progression-free survival in the above cohort of patients.
- Conditions
- Metastatic Cancer, Breast Cancer, Lobular Breast Carcinoma
- Being tested
- 18F-fluorofuranylnorprogesterone, Liquid Biopsy, Positron Emission Tomography/Computed Tomography
- Keywords
- Endocrine Therapy Resistance, circulating tumor cell, liquid biopsy
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms, Carcinoma, Lobular, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluorofuranylnorprogesteroneDrug
Also called FFNP
The dose of the investigational imaging agent, FFNP, is approximately 7 millicurie (mCi) (259 megabecquerels (MBq)), IV slow infusion over approximately two minutes followed by saline flush.
Liquid BiopsyDevice
Also called Circulating Tumor Cells (CTC)
20ml of whole blood will be collected into two Ethylenediaminetetraacetic acid (EDTA) tubes at each timepoint, CTCs are isolated using the microfluidic Versatile Exclusion-based Rare Sample Analysis (VERSA) platform that integrates CTC capture with RNA extraction on a single chip using Exclusion-Based Sample Preparation (ESP) technology
Positron Emission Tomography/Computed TomographyDevice
Also called PET/CT
FFNP drug in combination with PET/CT scans to image participant
| Study group | Role | What they receive |
|---|---|---|
| Participants with ER/PR+ metastatic lobular breast cancer (LBC) | Experimental | Not described Receives: Drug: 18F-fluorofuranylnorprogesterone; Device: Liquid Biopsy; Device: Positron Emission Tomography/Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy
Measured: baseline, 4 weeks
Number of Participants who have decrease in circulating tumor cell estrogen signaling in response to endocrine therapy
Baseline level and on-treatment CTC ESR1 and estrogen regulated gene expression will be evaluated as well as endocrine-resistance associated mutations including ESR1 (though rare in this patient population) and PGR.
Measured: baseline, 4 weeks
Number of Participants who have a decrease in concentration of Circulating Tumor DNA in response to endocrine therapy
Measured: baseline, 4 weeks
Secondary outcomes (3)
Progression Free Survival (PFS) for 6 months
Measured: up to 6 months
Correlation coefficients
Correlate baseline levels and dynamic on treatment changes in estrogen signaling as measured by FFNP-PET/CT and CTC liquid biopsy with clinical response to endocrine therapy and progression-free survival in patients with ER/PR+ metastatic LBC.
Measured: up to 6 months
Adverse Events within 24 hours of FFNP infusion
Measured: a 24 hour period up to 7 days pre-treatment, a 24 hour period 4 weeks after the first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start30 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina Sharifi, MD, PHD, Principal investigator, UW Carbone Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067503
- Sponsor's protocol ID
- 2023-1103
- Other IDs
- Protocol Version 10/2/2023, SMPH/MEDICINE/HEM-ONC, UW23076
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study may be requested from other researchers up to 7 years after the completion of the primary endpoint by contacting the University of Wisconsin Carbone Cancer Center (UWCCC)
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer
- ClinicalTrials.gov ID
- NCT06067503
- Acronym / sponsor ID
- 2023-1103
- Conditions
- Metastatic Cancer, Breast Cancer, Lobular Breast Carcinoma
- Keywords
- Endocrine Therapy Resistance, circulating tumor cell, liquid biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Oct 2023 (actual)
- 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.
This pilot observational study is being done to identify possible biomarkers of response to endocrine therapy in patients with ER/PR+ metastatic lobular breast cancer (LBC) starting new endocrine therapy. 18F-fluorofuranylnorprogesterone Positron Emission Tomography/Computed Tomography (FFNP-PET/CT) and liquid biopsies will be performed at baseline and after 4 weeks of treatment. Baseline levels and dynamic on-treatment changes in estrogen signaling as measured by FFNP-PET/CT and circulating tumor cell (CTC) liquid biopsy will be correlated with clinical response to endocrine therapy and progression-free survival in the above cohort of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with ER/PR+ metastatic lobular breast cancer (LBC) | Experimental | Drug: 18F-fluorofuranylnorprogesterone, Device: Liquid Biopsy, Device: Positron Emission Tomography/Computed Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to provide informed consent
- Individuals at least 18 years of age
- Have biopsy-proven ER/PR-positive (defined as ER ≥1 percent and PR ≥1 percent by IHC) and HER2-negative advanced or metastatic LBC starting new standard of care endocrine therapy
- Adequate organ function as indicated by standard laboratory tests (CBC, liver function tests or CMP) allowing for systemic breast cancer treatment per treating oncologist
- Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible
Key exclusion criteria (8 listed)
- Patients with active brain metastases
- Patients with liver-only disease are not eligible due to high background liver activity related to the radiopharmaceutical's hepatobiliary route of elimination
- Unable to lie flat during or tolerate PET/CT
- Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
- Presence of liver failure as judged by patient's treating physician
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-fluorofuranylnorprogesteroneAlso: FFNPThe dose of the investigational imaging agent, FFNP, is approximately 7 millicurie (mCi) (259 megabecquerels (MBq)), IV slow infusion over approximately two minutes followed by saline flush. | Drug | Participants with ER/PR+ metastatic lobular breast cancer (LBC) |
| Liquid BiopsyAlso: Circulating Tumor Cells (CTC)20ml of whole blood will be collected into two Ethylenediaminetetraacetic acid (EDTA) tubes at each timepoint, CTCs are isolated using the microfluidic Versatile Exclusion-based Rare Sample Analysis (VERSA) platform that integrates CTC capture with RNA extraction on a single chip using Exclusion-Based Sample Preparation (ESP) technology | Device | Participants with ER/PR+ metastatic lobular breast cancer (LBC) |
| Positron Emission Tomography/Computed TomographyAlso: PET/CTFFNP drug in combination with PET/CT scans to image participant | Device | Participants with ER/PR+ metastatic lobular breast cancer (LBC) |
Primary outcome
Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy
Time frame: baseline, 4 weeks
Number of Participants who have decrease in circulating tumor cell estrogen signaling in response to endocrine therapy
Time frame: baseline, 4 weeks
Baseline level and on-treatment CTC ESR1 and estrogen regulated gene expression will be evaluated as well as endocrine-resistance associated mutations including ESR1 (though rare in this patient population) and PGR.
Number of Participants who have a decrease in concentration of Circulating Tumor DNA in response to endocrine therapy
Time frame: baseline, 4 weeks
3 secondary outcomes
Progression Free Survival (PFS) for 6 months
Time frame: up to 6 months
Correlation coefficients
Time frame: up to 6 months
Adverse Events within 24 hours of FFNP infusion
Time frame: a 24 hour period up to 7 days pre-treatment, a 24 hour period 4 weeks after the first infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. Data from this study may be requested from other researchers up to 7 years after the completion of the primary endpoint by contacting the University of Wisconsin Carbone Cancer Center (UWCCC)
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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.
Marina Sharifi, MD, PHD principal investigator
UW Carbone Cancer Center
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-fluorofuranylnorprogesterone, Liquid Biopsy and Positron Emission Tomography/Computed Tomography in people with Metastatic Cancer and Breast Cancer, run by University of Wisconsin, Madison 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy (time frame: baseline, 4 weeks). The study lists 3 primary outcomes in all. 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 Aug 2026.