Clinical trial NCT06067503: Biomarkers to Detect Endocrine Therapy Resistance
Official title: Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Cancer
Breast Cancer
Lobular Breast Carcinoma
Keywords: Endocrine Therapy Resistance
circulating tumor cell
liquid biopsy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy
timeFrame: baseline, 4 weeks
measure: Number of Participants who have decrease in circulating tumor cell estrogen signaling in response to endocrine therapy
timeFrame: baseline, 4 weeks
measure: Number of Participants who have a decrease in concentration of Circulating Tumor DNA in response to endocrine therapy
timeFrame: baseline, 4 weeks
Secondary outcomes:
measure: Progression Free Survival (PFS) for 6 months
timeFrame: up to 6 months
measure: Correlation coefficients
timeFrame: up to 6 months
measure: Adverse Events within 24 hours of FFNP infusion
timeFrame: a 24 hour period up to 7 days pre-treatment, a 24 hour period 4 weeks after the first infusion
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: UW Carbone Cancer Center
name: Marina Sharifi, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: