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

Description

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.

Conditions

Metastatic Invasive Lobular Carcinoma (mILC)

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Metastatic Invasive Lobular Carcinoma (mILC)
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Signed informed consent
  • 2. Patients must have histologically or cytologically confirmed invasive lobular breast cancer that is ER+ (\> 1% staining) and HER2-negative as per ASCO/CAP guidelines with radiographical or clinical evidence of metastatic disease
  • 1. Lobular histology as assessed on either tissue collected from a metastatic lesion or from the patient's primary breast tumor (in case of recurrent metastatic disease)
  • 2. Patients with mixed ductal/lobular (NST/ILC) tumors are eligible to participate (with the ultimate goal to evaluate 20 patients with pure ILC)
  • 3. Patients must have tumor tissue available for whole exome sequencing for Signatera assay design
  • 3. Prior therapies:
  • 1. Patients must not have received any therapy in the metastatic setting
  • 2. Patients could have received adjuvant therapy as indicated for their primary breast cancer
  • 4. Age ≥ 18 years
  • 5. Patients may be pre- or post-menopausal.
  • 1. Stage I-III breast cancer
  • 2. Lack of lobular histology on tumor tissue biopsy
  • 3. Other active cancer (previously treated cancer with no current evidence of disease is allowed)
  • 4. ctDNA assay development is unattainable due to insufficient tumor tissue or sequencing failure

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Julia Foldi,

Julia Foldi, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2026-10-31