RECRUITING

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

Conditions

Metastatic Invasive Lobular Carcinoma (mILC)CDK4/6 inhibitors (CDK4/6i)endocrine therapies (ET)estrogen and progesterone receptor (ER and PR) positive human epidermal growth factor receptor 2 (HER2)ctDNA (circulating tumor DNA)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2024-12-12

Study Completion:2026-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06666439

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Lucia Borasso, BA

CONTACT

4126413304

borrlm@upmc.edu

Kelsey Mitch, RN

CONTACT

4126412357

adamikka2@upmc.edu

Principal Investigator

Julia Foldi, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Julia Foldi

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12

Study Completion Date2026-10-31

Study Record Updates

Study Start Date2024-12-12

Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

CDK4/6 inhibitors (CDK4/6i)
endocrine therapies (ET)
estrogen and progesterone receptor (ER and PR) positive
human epidermal growth factor receptor 2 (HER2)
ctDNA (circulating tumor DNA)

Additional Relevant MeSH Terms

Metastatic Invasive Lobular Carcinoma (mILC)