NCT06666439 · Julia Foldi
Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer
(LBC-Monitor)
What this study 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.
View original scientific 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.
Interventions
DIAGNOSTIC_TEST
circulating tumor DNA (ctDNA)
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.
Primary outcome measures
Change in ctDNA
Time frame: Baseline, at 4 weeks, at 8 weeks, at 12 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations