Ohio State University Comprehensive Cancer Center
This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.
Primary Objective: To determine if a non-surgical approach to breast cancer patients with an exceptional response to NAC leads to similar recurrence rates compared to standard of care (SOC). Exploratory Objectives 1. To study personalized predictive biomarkers of response to chemotherapy and predictors of residual disease from tumor samples and circulating biomarkers. 2. To validate our internally developed deep learning model to predict pathological complete response (pCR) postNAC in breast cancer patients. Outline: This is a phase II trial that will accrue up to 84 participants. Patients…
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years or older 4. Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype 5. Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT) Exclusion Criteria: 1. Pregnancy or lactation 2. Inmate or prisoner 3. Treatment with an investigational drug or other…
Participants will receive standard of care neoadjuvant chemotherapy
Radiotherapy simulation parameters will be at the discretion of the treating physician to account for the patient's body habitus, tumor bed location, and tolerability of the prone or supine positions, however, the recommended approach will be whole-breast RT (WBRT) in the prone position, for cT1-3 N0 patients who achieve ecCR. For cT1-2 N1 patients who achieve ecCR WBRT with nodal inclusion and lymph node boost will be performed in the supine position.
Participants will undergo MRI
Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.
Participants undergo biopsy
Participants undergo blood and plasma collection
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