Monitoring tumor changes in metastatic lobular breast cancer using blood tests
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
This study is testing if tracking changes in tumor DNA from blood tests can help doctors better understand how well treatment is working for patients with advanced lobular breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06666439 on ClinicalTrials.gov |
What this trial studies
This observational study aims to track early changes in circulating tumor DNA (ctDNA) in patients with metastatic invasive lobular carcinoma (mILC) to improve treatment strategies. By analyzing ctDNA, researchers hope to provide a more accurate assessment of treatment response compared to traditional imaging methods. The study focuses on patients who are starting first-line endocrine therapy, with the goal of identifying optimal early timepoints for monitoring molecular response. This approach could lead to more personalized treatment plans based on the dynamics of ctDNA changes.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed ER+ HER2-negative invasive lobular breast cancer who have evidence of metastatic disease and have not yet received therapy in the metastatic setting.
Not a fit: Patients with early-stage breast cancer (Stage I-III) or those who have already received therapy for metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable more tailored and effective treatment strategies for patients with metastatic lobular breast cancer.
How similar studies have performed: While the use of ctDNA for monitoring treatment response is gaining traction, this specific approach in metastatic lobular breast cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: 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
Where this trial is running
Pittsburgh, Pennsylvania
- Magee Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Julia Foldi, MD, PhD — University of Pittsburgh
- Study coordinator: Lucia Borasso, BA
- Email: borrlm@upmc.edu
- Phone: 4126413304
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.