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Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer
Sponsor: Ohio State University Comprehensive Cancer Center
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2026-04-15
Completion Date
2027-12-31
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
Neoadjuvant Chemotherapy
Participants will receive standard of care neoadjuvant chemotherapy
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.
MRI
Participants will undergo MRI
Breast Cancer Surgery
Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.
Biopsy
Participants undergo biopsy
Biospecimen collection
Participants undergo blood and plasma collection
Locations (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States