Monitoring tumor changes in metastatic lobular breast cancer using blood tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.