Blood markers to predict immune side effects and benefit from pembrolizumab in early triple-negative breast cancer

Serum biomarkers to predict immune related adverse events and benefit from single agent pembrolizumab therapy in early stage triple negative breast cancer

NIH-funded research Arizona State University-Tempe Campus · NIH-11239761

This project looks at whether blood autoantibodies can show who is likely to get immune-related side effects or benefit from one year of pembrolizumab after early triple-negative breast cancer.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionArizona State University-Tempe Campus NIH-funded
Lab location1 site (Scottsdale, United States)
Project IDNIH-11239761 on NIH RePORTER

What this research studies

If you had early-stage triple-negative breast cancer and received one year of pembrolizumab (or were on the observation arm) in the SWOG S1418 trial, researchers will analyze your stored blood samples to look for autoantibodies. They will use immunoproteomics to measure many serum autoantibodies across more than 3,000 samples from 1,195 patients collected over time. The team will link those blood markers to who developed immune-related adverse events and who had treatment benefit to find predictive patterns. Because these tests use routine blood samples, any reliable markers could be adapted into clinical blood tests.

Who could benefit from this research

Good fit: People with early-stage triple-negative breast cancer who received or are eligible for one-year adjuvant pembrolizumab (like participants in SWOG S1418) are the ideal candidates for this biomarker approach.

Not a fit: Patients without triple-negative breast cancer or those not treated with immune checkpoint inhibitors are unlikely to benefit from these specific biomarkers.

Why it matters

Potential benefit: If successful, blood tests could help predict who will get serious immune side effects and who is most likely to benefit from pembrolizumab, allowing more personalized and safer treatment choices.

How similar studies have performed: Some prior studies have hinted that blood markers and autoantibodies relate to immune therapy response or toxicity, but no widely used clinical test exists yet, so this approach is promising but still relatively novel.

Where this research is happening

Scottsdale, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Autoimmune Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.