Phase
Condition
Cancer
Breast Cancer
Neoplasm Metastasis
Treatment
Liquid Biopsy
Positron Emission Tomography/Computed Tomography
18F-fluorofuranylnorprogesterone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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 byIHC) and HER2-negative advanced or metastatic LBC starting new standard of careendocrine therapy
Adequate organ function as indicated by standard laboratory tests (CBC, liverfunction tests or CMP) allowing for systemic breast cancer treatment per treatingoncologist
Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic areeligible
Willing to comply with all study procedures and be available for the duration of thestudy
Disease may be measurable by RECIST 1.1 criteria or non-measurable. Lesion size mustbe at least 1cm. If only bone lesions present, they should be lytic or mixedlytic-sclerotic. If only liver lesions present, patient is not eligible.
Exclusion
Exclusion Criteria:
Patients with active brain metastases
Patients with liver-only disease are not eligible due to high background liveractivity 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 similarchemical 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 thestudy
Not suitable for study participation due to other reasons at the discretion of theinvestigators
Patients with progesterone-receptor negative disease defined as PR <1 percent by IHC
Study Design
Connect with a study center
UW Carbone Cancer Center
Madison, Wisconsin 53792
United StatesActive - Recruiting

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