Recruiting

Observational Study

Sponsor:

Julia Foldi

Code:

NCT06666439

Conditions

Metastatic Invasive Lobular Carcinoma (mILC)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

circulating tumor DNA (ctDNA)

Study Details

Brief summary:

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

Metastatic Invasive Lobular Carcinoma (mILC)

Study ID

NCT06666439

Start date

Dec 12, 2024

Status verified date

Jan, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Oct 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 measure

  • Change in ctDNA [ Time Frame: Baseline, at 4 weeks, at 8 weeks, at 12 weeks ]

Central Contacts and Locations

Central contacts

Lucia Borasso, BA

4126413304borrlm@upmc.edu

Kelsey Mitch, RN

4126412357adamikka2@upmc.edu

Locations

Magee Women's Hospital of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Lucia Borasso, BA

4126413304borrlm@upmc.edu

Kelsey Mitch, RN

4126412357adamikka2@upmc.edu

Principal Investigator:

Julia Foldi, MD, PhD

More Information

Sponsor

Julia Foldi

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • CDK4/6 inhibitors (CDK4/6i)
  • endocrine therapies (ET)
  • estrogen and progesterone receptor (ER and PR) positive
  • human epidermal growth factor receptor 2 (HER2)
  • ctDNA (circulating tumor DNA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Julia Foldi on 2026-01-20.