Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer (NoCUT-BC)

The Ohio State University

Status and phase: Not yet enrolling; Phase 2; Phase 1

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

Treatments: Procedure: Breast Cancer Surgery; Procedure: Biospecimen collection; Procedure: Biopsy; Drug: Neoadjuvant Chemotherapy; Radiation: Radiation Therapy; Procedure: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT07217990

OSU-25103

NCI-2025-07434 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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

1. To study personalized predictive biomarkers of response to chemotherapy and predictors of residual disease from tumor samples and circulating biomarkers.
2. 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).

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years or older
4. 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
5. Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Arm A (eeCR, non-surgical)

Experimental group

Description:

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.

Treatment:

Radiation: Radiation Therapy

Procedure: Biospecimen collection

Drug: Neoadjuvant Chemotherapy

Procedure: Biopsy

Procedure: MRI

Arm B (non-eeCR, surgical)

Experimental group

Description:

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.

Treatment:

Radiation: Radiation Therapy

Procedure: Biospecimen collection

Drug: Neoadjuvant Chemotherapy

Procedure: Biopsy

Procedure: Breast Cancer Surgery

Procedure: MRI