Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer

Conditions

• Metastatic Invasive Lobular Carcinoma (mILC)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• circulating tumor DNA (ctDNA) — DIAGNOSTIC_TEST
  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.

Study Details

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.

Key Dates

Start date

Dec 12, 2024

Status verified

Jan 2026

Primary completion

Oct 31, 2029

Completion

Oct 31, 2029

Study Design

Enrollment

20 participants (estimated)

Primary Outcome Measure

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

Central Contacts

• Lucia Borasso, BA
  4126413304
  [email protected]
• Kelsey Mitch, RN
  4126412357
  [email protected]

Locations (1)

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