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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tracks early changes in tumor DNA found in the blood, called ctDNA. It is for adults with lobular breast cancer that has spread to other parts of the body. The study looks at whether these changes could help guide when to increase or reduce treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign a form agreeing to take part after learning about the study.
- Be age 18 or older.
- Have invasive lobular breast cancer confirmed by tissue or cell testing. This cancer starts in the breast’s milk-making glands. Mixed ductal and lobular cancers are also allowed.
- Have cancer that is estrogen receptor-positive (ER+, with more than 1% staining) and HER2-negative. These tests check features that help guide treatment.
- Have scans or a medical exam showing that the cancer has spread to other parts of the body.
- Have tumor tissue available for DNA testing to design a personal Signatera blood test.
- Have had no treatment for breast cancer that has spread. Earlier treatment for the original breast cancer is allowed.
- People who have or have not gone through menopause may join.
Who can't join
- Have stage I–III breast cancer, rather than cancer that has spread to distant parts of the body.
- Have no lobular cancer found in the tumor tissue sample.
- Have another active cancer. A past cancer that was treated and has no current signs is allowed.
- The tumor DNA blood test cannot be made because there is too little tumor tissue or the DNA testing fails.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
PA
- Magee Women's Hospital of UPMC · Pittsburgh, PA 15213Lucia Borasso, BA · Study contact · 4126413304 · borrlm@upmc.eduKelsey Mitch, RN · Study contact · 4126412357 · adamikka2@upmc.eduJulia Foldi, MD, PhD · Principal investigatorMore trials in Pittsburgh