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New treatment option for Metastatic Cancer
Official title Biomarkers to Detect Endocrine Therapy Resistance
ClinicalTrials.gov ID: NCT06067503
What this study is testing
What is 18F-fluorofuranylnorprogesterone?
18F-fluorofuranylnorprogesterone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic cancer.
Also referred to as FFNP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Adequate organ function as indicated by standard laboratory tests (CBC, liver function tests or CMP) allowing for systemic breast cancer treatment...
- Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.