Using a more precise HER2 protein test to find breast cancer patients who could benefit from trastuzumab-deruxtecan
Research Project 1
This project looks at whether a more precise lab test for HER2 protein can identify breast cancer patients, including those called HER2-low or HER2-zero, who may benefit from the drug trastuzumab-deruxtecan (DS-8201a).
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Washington University NIH-funded |
| Lab location | 1 site (Saint Louis, United States) |
| Project ID | NIH-11172474 on NIH RePORTER |
What this research studies
Antibody-drug conjugates like trastuzumab-deruxtecan deliver chemotherapy directly to HER2-expressing cancer cells, and some patients classified as HER2-low or HER2-zero by standard IHC have still responded. The team will use a mass-spectrometry based CLIA assay (MRM-MS) that measures HER2 protein over a wider range than routine tests, running it on tumor samples. They will compare those quantitative HER2 levels with clinical responses to DS-8201a to see if the new test better predicts who benefits. The work aims to improve patient selection for this targeted chemotherapy and may involve sending samples to a certified lab or enrolling at participating centers.
Who could benefit from this research
Good fit: Ideal candidates are people with breast cancer classified as HER2-low or HER2 0 by routine IHC (IHC 0–2+/ISH-) who have available tumor tissue and are eligible for or have received DS-8201a treatment.
Not a fit: Patients whose tumors clearly lack HER2 protein by multiple testing methods or those with cancers unrelated to HER2-driven biology are unlikely to benefit from this HER2-targeted approach.
Why it matters
Potential benefit: If successful, the assay could help more accurately select breast cancer patients who are likely to benefit from trastuzumab-deruxtecan, potentially expanding treatment to some labeled HER2-low or HER2-zero.
How similar studies have performed: Trastuzumab-deruxtecan has shown benefit in clinical trials for HER2-positive and HER2-low breast cancers, but using a mass-spectrometry HER2 assay to predict response is a newer and relatively untested approach.
Where this research is happening
Saint Louis, United States
- Washington University — Saint Louis, United States (Active)
Researchers
- Principal investigator: Ma, Cynthia X — Washington University
- Study coordinator: Ma, Cynthia X
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.