Identifying biomarkers for endocrine therapy resistance in lobular breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot observational study aims to identify potential biomarkers that indicate response to endocrine therapy in patients with ER/PR-positive metastatic lobular breast cancer. Participants will undergo 18F-fluorofuranylnorprogesterone Positron Emission Tomography/Computed Tomography (FFNP-PET/CT) and liquid biopsies at the start of treatment and after four weeks. The study will correlate baseline levels and changes in estrogen signaling, as measured by FFNP-PET/CT and circulating tumor cells, with clinical responses and progression-free survival. This approach seeks to enhance understanding of treatment resistance in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing to provide informed consent
2. Individuals at least 18 years of age
3. 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
4. Adequate organ function as indicated by standard laboratory tests (CBC, liver function tests or CMP) allowing for systemic breast cancer treatment per treating oncologist
5. Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible
6. Willing to comply with all study procedures and be available for the duration of the study
7. 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.

Exclusion Criteria:

1. Patients with active brain metastases
2. Patients with liver-only disease are not eligible due to high background liver activity related to the radiopharmaceutical's hepatobiliary route of elimination
3. Unable to lie flat during or tolerate PET/CT
4. Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
5. Presence of liver failure as judged by patient's treating physician
6. Individuals who are pregnant, lactating, or planning on becoming pregnant during the study
7. Not suitable for study participation due to other reasons at the discretion of the investigators
8. Patients with progesterone-receptor negative disease defined as PR \<1 percent by IHC

Where it's running

• UW Carbone Cancer Center
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Marina Sharifi, MD, PHD — UW Carbone Cancer Center
• Study coordinator: Cancer Connect
• Email: clinicaltrials@cancer.wisc.edu
• Phone: 800-622-8922

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.