Breast CancerPhase 1/2NoCUT-BCNCT07217990
Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer
A Phase 1/2 study testing Neoadjuvant Chemotherapy, Radiation Therapy and MRI in people with Breast Cancer and HER2-positive Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Neoadjuvant Chemotherapy, Radiation Therapy and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Sachin Jhawar, MD, Sachin.Jhawar@osumc.edu
Sachin Jhawar, MD
About this study
This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.
Read the 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
- 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).
- Being tested
- Neoadjuvant Chemotherapy, Radiation Therapy, MRI, Breast Cancer Surgery, Biopsy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant ChemotherapyDrug
Participants will receive standard of care neoadjuvant chemotherapy
Radiation TherapyRadiation
Also called Radiotherapy
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.
MRIProcedure or surgery
Also called Magnetic Resonance Imaging
Participants will undergo MRI
Breast Cancer SurgeryProcedure or surgery
Also called Lumpectomy, Mastectomy
Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.
BiopsyProcedure or surgery
Participants undergo biopsy
Biospecimen collectionProcedure or surgery
Participants undergo blood and plasma collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Neoadjuvant Chemotherapy; Radiation: Radiation Therapy; Procedure: MRI; Procedure: Breast Cancer Surgery; Procedure: Biopsy; Procedure: Biospecimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months
Secondary outcomes (3)
Locoregional control
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.
Measured: At 2, 3 and 5 years
Disease-free survival
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.
Measured: Up to 5 years
Treatment related adverse events
Toxicities will be recorded using CTCAE v5.0
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gateway for Cancer Research
- Responsible party
- Principal investigator, Sachin Jhawar, Ohio State University Comprehensive Cancer Center
- Investigators
- Sachin Jhawar, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217990
- Sponsor's protocol ID
- OSU-25103
- Other IDs
- NCI-2025-07434
- Acronym
- NoCUT-BC
- Status last verified
- Jun 2026
- First submitted
- 15 Oct 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer
- ClinicalTrials.gov ID
- NCT07217990
- Acronym / sponsor ID
- NoCUT-BC / OSU-25103
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Gateway for Cancer Research
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (eeCR, non-surgical) | Experimental | Drug: Neoadjuvant Chemotherapy, Radiation: Radiation Therapy, Procedure: MRI, Procedure: Biopsy, Procedure: Biospecimen collectionPatients 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. |
| Arm B (non-eeCR, surgical) | Experimental | Drug: Neoadjuvant Chemotherapy, Radiation: Radiation Therapy, Procedure: MRI, Procedure: Breast Cancer Surgery, Procedure: Biopsy, Procedure: Biospecimen collectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant ChemotherapyParticipants will receive standard of care neoadjuvant chemotherapy | Drug | Arm A (eeCR, non-surgical), Arm B (non-eeCR, surgical) |
| Radiation TherapyAlso: RadiotherapyRadiotherapy 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. | Radiation | Arm A (eeCR, non-surgical), Arm B (non-eeCR, surgical) |
| MRIAlso: Magnetic Resonance ImagingParticipants will undergo MRI | Procedure or surgery | Arm A (eeCR, non-surgical), Arm B (non-eeCR, surgical) |
| Breast Cancer SurgeryAlso: Lumpectomy, MastectomyParticipants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed. | Procedure or surgery | Arm B (non-eeCR, surgical) |
| BiopsyParticipants undergo biopsy | Procedure or surgery | Arm A (eeCR, non-surgical), Arm B (non-eeCR, surgical) |
| Biospecimen collectionParticipants undergo blood and plasma collection | Procedure or surgery | Arm A (eeCR, non-surgical), Arm B (non-eeCR, surgical) |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Sachin Jhawar, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neoadjuvant Chemotherapy, Radiation Therapy and MRI in people with Breast Cancer and HER2-positive Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Rate (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.