RecruitingNCT06666439

Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer

LBC-Monitor: Liquid Biopsy Guided Tailoring of Therapy in Metastatic Lobular Breast Cancer (mILC): A Pilot Study of Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA


Sponsor

Julia Foldi

Enrollment

20 participants

Start Date

Dec 12, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this study is to characterize early dynamic changes in ctDNA, which can aid in tailoring early therapy in patients with metastatic Invasive lobular carcinoma (ILC). Response assessment using ctDNA analysis could not only aid in de-escalation but also escalation strategies.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking circulating tumor DNA (ctDNA) — fragments of DNA shed by cancer cells into the bloodstream — in people with metastatic lobular breast cancer (a specific type of ER-positive, HER2-negative breast cancer known for being harder to detect on scans) to see if blood tests can monitor how well treatment is working over time. **You may be eligible if...** - You are 18 or older - You have been diagnosed with invasive lobular breast cancer (or mixed ductal/lobular) that is ER-positive and HER2-negative - Your cancer has spread to other parts of the body (metastatic) but you have NOT yet started any treatment for the metastatic stage - Tumor tissue from your breast cancer is available for genetic analysis **You may NOT be eligible if...** - Your breast cancer is still in an early, non-metastatic stage (Stage I-III) - Your tumor does not have lobular features on biopsy - You have another active cancer at the same time - Sufficient tumor tissue is not available for genetic testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTcirculating tumor DNA (ctDNA)

Signatera is based on a custom-designed multiplex polymerase chain reaction (mPCR) assay for each patient, targeting up to 16 mutations found in the patient's tumor during whole exome sequencing (WES) to create a unique tumor mutation signature.


Locations(1)

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, United States

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NCT06666439