Clinical trial · Observational
Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer
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
NCT06666439CI-TRIAL-00101201LBC-MonitorrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Invasive Lobular Carcinoma (mILC) | Invasive Breast Lobular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| circulating tumor DNA (ctDNA) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in ctDNA
- timeFrame
- Baseline, at 4 weeks, at 8 weeks, at 12 weeks
- description
- 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.
Secondary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- Up to 2 years
- description
- Length of time from start of treatment that patients live without disease progression per RECIST v1.1 in those with measurable disease on imaging. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Data will be collected only in patients who completed the initial 12-week lead-in period with antiestrogen treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.