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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

December 15, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Breast CancerHER2-positive Breast CancerTriple Negative Breast Cancer
Interventions
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

Trial Locations (1)

43210

Ohio State University Comprehensive Cancer Center, Columbus

All Listed Sponsors
collaborator

Gateway for Cancer Research

OTHER

lead

Ohio State University Comprehensive Cancer Center

OTHER