NCT07217990

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.

Detailed description

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).

Conditions

• Breast Cancer
• HER2-positive Breast Cancer
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant Chemotherapy	Participants will receive standard of care neoadjuvant chemotherapy
RADIATION	Radiation Therapy	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.
PROCEDURE	MRI	Participants will undergo MRI
PROCEDURE	Breast Cancer Surgery	Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.
PROCEDURE	Biopsy	Participants undergo biopsy
PROCEDURE	Biospecimen collection	Participants undergo blood and plasma collection

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-10-20
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study