Best radiation dose with pre-surgery chemo and pembrolizumab for early-stage triple-negative breast cancer
Defining Optimal Radiotherapy Dose and Fractionation in Combination with Preoperative Immuno-Chemotherapy in Early-Stage Triple Negative Breast Cancer
This project compares different radiation doses given before surgery together with chemotherapy and pembrolizumab for people with early-stage, node-positive triple-negative breast cancer to find the safest and most helpful approach.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Univ of North Carolina Chapel Hill NIH-funded |
| Lab location | 1 site (Chapel Hill, United States) |
| Project ID | NIH-10880515 on NIH RePORTER |
What this research studies
If you have node-positive, early-stage triple-negative breast cancer, this project will add varying doses of radiation before surgery alongside standard chemotherapy and the immune drug pembrolizumab. Patients will be randomly assigned to receive no radiation, a low dose, or a high dose before their planned surgery, and the team will monitor tumor response and side effects. The work builds on earlier small trials that showed the combination can be safe and may help some patients. The goal is to pinpoint which radiation dose best helps the immune therapy and chemotherapy work together.
Who could benefit from this research
Good fit: Adults with early-stage, node-positive, HER2-negative triple-negative breast cancer who are planning to receive neoadjuvant chemotherapy and pembrolizumab would be the ideal candidates.
Not a fit: People without triple-negative breast cancer, those who are node-negative, or those not receiving neoadjuvant pembrolizumab and chemotherapy are unlikely to be eligible or benefit from this work.
Why it matters
Potential benefit: If successful, this could increase the number of patients whose tumors disappear before surgery and lower the chance of recurrence by finding the radiation dose that best boosts immune and chemotherapy effects.
How similar studies have performed: Early pilot trials combining radiation with pembrolizumab in triple-negative breast cancer have shown the approach can be safe and produced early signs of benefit, but the optimal radiation dose has not yet been defined.
Where this research is happening
Chapel Hill, United States
- Univ of North Carolina Chapel Hill — Chapel Hill, United States (Active)
Researchers
- Principal investigator: Gupta, Gaorav P. — Univ of North Carolina Chapel Hill
- Study coordinator: Gupta, Gaorav P.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.