Who is eligible for clinical trial NCT06067503?

Participants must meet the protocol's inclusion criteria for Metastatic Cancer. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06067503 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-24

Biomarkers to Detect Endocrine Therapy Resistance (NCT06067503)

Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of Wisconsin, Madison

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (9 items).

Location: UW Carbone Cancer Center — Madison, Wisconsin

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

UW Carbone Cancer Center — Madison, Wisconsin

📞 Contact the Study Coordinator

Phone: (800) 622-8922

Email: clinicaltrials@cancer.wisc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗