Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07217990

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

This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms HER2-positive Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Cancer Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location contact

Sachin Jhawar, MD

CONTACT

[email protected]

Sachin Jhawar, MD

PRINCIPAL_INVESTIGATOR

About this study

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

  • To study personalized predictive biomarkers of response to chemotherapy and predictors of residual disease from tumor samples and circulating biomarkers.
  • To validate our internally developed deep learning model to predict pathological complete response (pCR) postNAC in breast cancer patients.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Neoadjuvant chemotherapy

Drug

Participants will receive standard of care neoadjuvant chemotherapy

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.

Other names: Radiotherapy

MRI

Procedure

Participants will undergo MRI

Other names: Magnetic Resonance Imaging

Breast cancer surgery

Procedure

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

Other names: Lumpectomy, Mastectomy

Biopsy

Procedure

Participants undergo biopsy

Biospecimen Collection

Procedure

Participants undergo blood and plasma collection

Primary outcomes

  1. Disease-Free Rate

    Time frame: At 12 months

    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.

Secondary outcomes

  1. Locoregional control

    Time frame: At 2, 3 and 5 years

    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.

  2. Disease-free survival

    Time frame: Up to 5 years

    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.

  3. Treatment related adverse events

    Time frame: Up to 5 years

    Toxicities will be recorded using CTCAE v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Gateway for Cancer Research

Registry information

Acronym: NoCUT-BC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.