IRB Study Number 23-237
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objective:
i. To perform a feasibility study on circulating tumor DNA (ctDNA) detection and quantification at diagnosis and different time points in patients with biopsy proven, anatomic stage II-III invasive lobular cancer (ILC)
Secondary Objectives:
ii. Calculation of the sensitivity of ctDNA against the gold standard, which is breast pathology results.
iii. Correlation between ctDNA and residual disease and risk of early/late recurrence after neoadjuvant therapy (NAT)
iv. Evaluate the correlation and added benefit of radiomics by analyzing conventional breast MRI in the ability to predict variation in disease behavior, including response to treatment
v. Exploring serial plasma-based genotyping to track ILC evolution, change in mutational profile and identification of mutations that can provide information on effectiveness of therapy or resistance
vi. If available, will assess ctDNA correlation with MammaPrint/OncotypeDx results
vii. Explore potential barriers related to obtaining ctDNA
viii. Assess comprehensive genomic profiling (CGP) and evaluate change in mutational profile over time, particularly after NAT
Inclusion Criteria
• Any patient (man/woman) age ≥ 18
• Biopsy proven invasive lobular cancer
• Anatomic stages II or III
• Must be fit (per physician discretion) and agreeable to undergo breast cancer treatment at Cleveland Clinic per physician discretion
• Able to provide own consent for the study
Exclusion Criteria
• Any other type of biopsy proven invasive breast cancer that is not lobular (ie: ductal, mixed, other)
• Stages 0 (carcinoma in situ), stage I or stage IV
• Patients deemed by their oncologist to not be suitable for breast cancer treatment
