Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer
NCT ID: NCT07217990
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
84 participants
INTERVENTIONAL
2025-12-15
2027-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (eeCR, non-surgical)
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.
Neoadjuvant Chemotherapy
Participants will receive standard of care neoadjuvant chemotherapy
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.
MRI
Participants will undergo MRI
Biopsy
Participants undergo biopsy
Biospecimen collection
Participants undergo blood and plasma collection
Arm B (non-eeCR, surgical)
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.
Neoadjuvant Chemotherapy
Participants will receive standard of care neoadjuvant chemotherapy
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.
MRI
Participants will undergo MRI
Breast Cancer Surgery
Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.
Biopsy
Participants undergo biopsy
Biospecimen collection
Participants undergo blood and plasma collection
Interventions
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Neoadjuvant Chemotherapy
Participants will receive standard of care neoadjuvant chemotherapy
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.
MRI
Participants will undergo MRI
Breast Cancer Surgery
Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.
Biopsy
Participants undergo biopsy
Biospecimen collection
Participants undergo blood and plasma collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Gateway for Cancer Research
OTHER
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Sachin Jhawar
Principal Investigator
Principal Investigators
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Sachin Jhawar, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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The Jamesline
Other Identifiers
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NCI-2025-07434
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-25103
Identifier Type: -
Identifier Source: org_study_id
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