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

NCT07217990 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: OSU-25103NCI-2025-07434
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Triple Negative Breast Cancer; Breast Cancer; HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  At 12 months

Secondary Outcomes (3)

• Locoregional control

  At 2, 3 and 5 years

• Disease-free survival

  Up to 5 years

• Treatment related adverse events

  Up to 5 years

Study Arms (2)

Arm A (eeCR, non-surgical)

EXPERIMENTAL

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

Arm B (non-eeCR, surgical)

EXPERIMENTAL

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

Interventions

Radiation Therapy RADIATION

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

Arm A (eeCR, non-surgical); Arm B (non-eeCR, surgical)

Neoadjuvant Chemotherapy DRUG

Participants will receive standard of care neoadjuvant chemotherapy

Arm A (eeCR, non-surgical); Arm B (non-eeCR, surgical)

MRI PROCEDURE

Participants will undergo MRI

Also known as: Magnetic Resonance Imaging

Arm A (eeCR, non-surgical); Arm B (non-eeCR, surgical)

Breast Cancer Surgery PROCEDURE

Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.

Also known as: Lumpectomy, Mastectomy

Arm B (non-eeCR, surgical)

Biopsy PROCEDURE

Participants undergo biopsy

Arm A (eeCR, non-surgical); Arm B (non-eeCR, surgical)

Biospecimen collection PROCEDURE

Participants undergo blood and plasma collection

Arm A (eeCR, non-surgical); Arm B (non-eeCR, surgical)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 years or older
• 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
• Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT)

You may not qualify if:

• Pregnancy or lactation
• Inmate or prisoner
• Treatment with an investigational drug or other intervention throughout their breast cancer treatment
• Patients with skin involvement and/or distant metastases

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Gateway for Cancer Research: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Neoadjuvant Therapy; Radiotherapy; Magnetic Resonance Spectroscopy; Mastectomy, Segmental; Mastectomy; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Surgical Procedures, Operative; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical

Study Officials

• Sachin Jhawar, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 20, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)