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Biomarker Testing for Breast Cancer Treatment Resistance

Phase 2

Recruiting

Led By Marina Sharifi, MD, PHD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial will test biomarkers to see if they predict how well endocrine therapy works in ER/PR+ metastatic LBC patients. FFNP-PET/CT and liquid biopsies will be used to measure response to treatment.

Who is the study for?

This trial is for adults with ER/PR+ metastatic lobular breast cancer who are starting new endocrine therapy. They must have adequate organ function, lesions of at least 1cm (or specific bone lesions), and not just liver disease. Pregnant individuals or those with brain metastases, liver failure, allergies to similar compounds as FFNP, or progesterone-receptor negative disease cannot participate.Check my eligibility

What is being tested?

The study aims to find biomarkers predicting the response to endocrine therapy in patients using two methods: FFNP-PET/CT scans and liquid biopsies before and after four weeks of treatment. The results will be linked to how well the therapy works and how long patients live without their cancer getting worse.See study design

What are the potential side effects?

While this observational study primarily focuses on imaging and biopsy procedures rather than drug side effects, potential risks may include discomfort from PET/CT scans, reactions at the biopsy site, exposure to radiation from scans, and possible allergic reactions to FFNP.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is ER/PR-positive and HER2-negative, starting new hormone therapy.

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My cancer has spread to my bones, showing lytic or mixed features.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants who have a decrease in concentration of Circulating Tumor DNA in response to endocrine therapy

Number of Participants who have decrease in circulating tumor cell estrogen signaling in response to endocrine therapy

Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy

Secondary outcome measures

Adverse Events within 24 hours of FFNP infusion

Correlation coefficients

Progression Free Survival (PFS) for 6 months

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with ER/PR+ metastatic lobular breast cancer (LBC)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography/Computed Tomography

2020

Completed Phase 2

~20

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,538 Total Patients Enrolled

35 Trials studying Breast Cancer

38,511 Patients Enrolled for Breast Cancer

Marina Sharifi, MD, PHDPrincipal InvestigatorUW Carbone Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being admitted to this experiment?

"Clinicaltrials.gov attests to this study's inactivity; it was first published on January 1st 2024 and the last update occurred on September 27th 2023. Although recruitment is no longer underway, other trials are actively acquiring participants at present - 2867 studies to be exact."

Answered by AI

What potential risks do individuals with ER/PR+ metastatic lobular breast cancer (LBC) face?

"We assess the safety of participants with ER/PR+ metastatic lobular breast cancer (LBC) to be a 2, as this is Phase 2 trial. While there exists some evidence for its safety, there are no trials that have evaluated its efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biomarkers to Detect Endocrine Therapy Resistance

2024. "Biomarkers to Detect Endocrine Therapy Resistance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067503.