A Phase 1/2 interventional study of Neoadjuvant Chemotherapy and Radiation Therapy in Breast Cancer, HER2-positive Breast Cancer and Triple Negative Breast Cancer, sponsored by Ohio State University Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Ohio State University Comprehensive Cancer Center · Phase 1/2, Interventional, and Treatment
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
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).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 84 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who achieve an ecCR will be placed in the non-surgical arm. Participants will receive radiation therapy and routine and additional screening MRIs during follow up.
Drug: Neoadjuvant Chemotherapy · Radiation: Radiation Therapy · Procedure: MRI · Procedure: Biopsy · Procedure: Biospecimen collection
Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who do not achieve an ecCR will be placed in the surgical arm. Participants will undergo a lumpectomy or mastectomy, receive radiation therapy, and routine follow-up.
Drug: Neoadjuvant Chemotherapy · Radiation: Radiation Therapy · Procedure: MRI · Procedure: Breast Cancer Surgery · Procedure: Biopsy · Procedure: Biospecimen collection
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.
Also known as: Radiotherapy
Participants will undergo MRI
Also known as: Magnetic Resonance Imaging
Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.
Also known as: Lumpectomy, Mastectomy
Participants undergo biopsy
Participants undergo blood and plasma collection
Disease-Free Rate
The study endpoints of disease-free rate and locoregional control will be determined in patient follow up by utilizing MRIs, annual mammograms and clinical assessments in conjunction with ctDNA status.
Time frame: At 12 months
Locoregional control
The study endpoints of disease-free rate and locoregional control will be determined in patient follow up by utilizing MRIs, annual mammograms and clinical assessments in conjunction with ctDNA status.
Time frame: At 2, 3 and 5 years
Disease-free survival
Survival analysis will be conducted for time to event data, and the disease control or survival rate at specific times will be estimated based on the survival analysis along with the 95% CI.
Time frame: Up to 5 years
Treatment related adverse events
Toxicities will be recorded using CTCAE v5.0
Time frame: Up to 5 years
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center