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

NCT06666439 | Recruiting DMC FDA Device

• 1 other identifier: HCC 24-096
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Invasive Lobular Carcinoma (mILC)

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• Change in ctDNA

  Change in circulating tumor DNA (ctDNA) is measured by MTM/ml in patients receiving first line endocrine therapy (an aromatase inhibitor or fulvestrant) for metastatic lobular breast cancer.

  Baseline, at 4 weeks, at 8 weeks, at 12 weeks

Secondary Outcomes (1)

• Progression free survival (PFS)

  Up to 2 years

Interventions

circulating tumor DNA (ctDNA) DIAGNOSTIC_TEST

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.

Also known as: Signatera

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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, who plan to begin first line endocrine therapy with an aromatase inhibitor or fulvestrant alone for 12 weeks.

You may qualify if:

• Signed informed consent
• 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
• 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)
• Patients with mixed ductal/lobular (NST/ILC) tumors are eligible to participate (with the ultimate goal to evaluate 20 patients with pure ILC)
• Patients must have tumor tissue available for whole exome sequencing for Signatera assay design
• Prior therapies:
• Patients must not have received any therapy in the metastatic setting
• Patients could have received adjuvant therapy as indicated for their primary breast cancer
• Age ≥ 18 years
• Patients may be pre- or post-menopausal.

You may not qualify if:

• Stage I-III breast cancer
• Lack of lobular histology on tumor tissue biopsy
• Other active cancer (previously treated cancer with no current evidence of disease is allowed)
• ctDNA assay development is unattainable due to insufficient tumor tissue or sequencing failure

Sponsors & Collaborators

• Julia Foldi: lead

Study Sites (1)

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

circulating tumor DNA (ctDNA) - offers an alternative, minimally invasive approach for monitoring treatment response

MeSH Terms

Conditions

Carcinoma, Lobular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Julia Foldi, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Borasso, BA

CONTACT

4126413304; borrlm@upmc.edu

Kelsey Mitch, RN

CONTACT

4126412357; adamikka2@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)