Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer

Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer

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 will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. The ecCR will be evaluated using a trimodal approach, which includes the use to Magnetic Resonance Imaging (MRI), image-guided biopsy, and circulating tumor DNA (ctDNA) analysis. Participants who achieve an ecCR will be placed in the non-surgical arm (Arm A), while those who do not achieve an ecCR will be placed in the surgical arm (Arm B).

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 intervention throughout their breast cancer treatment
4. Patients with skin involvement and/or distant metastases