Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant Chemotherapy, Radiation Therapy, MRI, Breast Cancer Surgery.
- Who it may be relevant to
- Registry conditions: Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.
Detailed 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).
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
Primary outcome measures
- Disease-Free Rate [Time frame: At 12 months]
Secondary outcome measures (3)
- Locoregional control [Time frame: At 2, 3 and 5 years]
- Disease-free survival [Time frame: Up to 5 years]
- Treatment related adverse events [Time frame: Up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Ohio State University Comprehensive Cancer Center — Columbus
Identifiers
NCT: NCT07217990 · OSU-25103 · NCI-2025-07434