Breast Cancer Treatment Study: Non-Surgical Approach for Exceptional Responders

This study is looking at a new way to treat early-stage breast cancer that is HER2-positive or triple-negative. It aims to see if some patients who respond very well to standard chemotherapy (neoadjuvant chemotherapy, given before surgery) can avoid surgery. You would receive standard chemotherapy. Doctors will then use MRI scans, biopsies (taking small tissue samples), and blood tests to see how well your cancer responded. If your cancer has responded exceptionally well, you might be in a group that receives radiation therapy instead of surgery. If it hasn't responded as well, you would have standard breast cancer surgery (lumpectomy or mastectomy). The main goal is to see if this non-surgical approach leads to similar rates of being disease-free after 12 months compared to standard treatment. This study is for adults aged 18 and older with specific types of early-stage breast cancer.

Study design
This is a Phase 2 interventional study planning to enroll up to 84 participants. It compares a non-surgical approach to standard care based on how well a patient responds to initial chemotherapy.
What's involved
You would undergo neoadjuvant chemotherapy, MRI scans, biopsies, and potentially breast cancer surgery or radiation therapy. The duration of your participation is not fully specified, but disease-free rates will be measured at 12 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, disease-free rate, is measured at 12 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07217990

Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Ohio State University Comprehensive Cancer Center
~84 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Neoadjuvant ChemotherapyRadiation TherapyMRIBreast Cancer SurgeryBiopsyBiospecimen collection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-Free Rate
Measured over At 12 months
Breast Cancer
HER2-positive Breast Cancer
Triple Negative Breast Cancer
1 sites across 1 states
Ohio1
  • Sachin Jhawar, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
The Ohio State University Comprehensive Cancer Center
Email the study team

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  • Disease-Free RateAt 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.