Actively Recruiting
Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer
Led by Julia Foldi · Updated on 2026-01-20
20
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Histologically or cytologically confirmed invasive lobular breast cancer that is estrogen receptor positive (>1% staining) and HER2-negative
- Radiographical or clinical evidence of metastatic disease
- Lobular histology confirmed on metastatic lesion tissue or primary breast tumor tissue
- Patients with mixed ductal/lobular tumors are eligible
- Tumor tissue available for whole exome sequencing for Signatera assay design
- No prior therapy received for metastatic breast cancer
- Adjuvant therapy for primary breast cancer allowed
- Age 18 years or older
- Patients may be pre- or post-menopausal
You will not qualify if you...
- Stage I-III breast cancer
- Absence of lobular histology on tumor tissue biopsy
- Presence of other active cancer (previously treated cancer with no current evidence of disease allowed)
- Insufficient tumor tissue or sequencing failure preventing ctDNA assay development
AI-Screening
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Trial Site Locations
Total: 1 location
1
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
L
Lucia Borasso, BA
CONTACT
K
Kelsey Mitch, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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