Status:
NOT_YET_RECRUITING
Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Gateway for Cancer Research
Conditions:
Breast Cancer
HER2-positive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
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). Explorat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT07217990
Start Date
December 15 2025
End Date
December 31 2027
Last Update
October 17 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210