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

NCT07217990 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-02-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Gateway for Cancer Research

    collaborator OTHER

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Sachin Jhawar, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217990 on ClinicalTrials.gov