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.
Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Sachin Jhawar, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
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What this trial measures
- 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.