- McNamara, Katherine L;
- Caswell-Jin, Jennifer L;
- Joshi, Rohan;
- Ma, Zhicheng;
- Kotler, Eran;
- Bean, Gregory R;
- Kriner, Michelle;
- Zhou, Zoey;
- Hoang, Margaret;
- Beechem, Joseph;
- Zoeller, Jason;
- Press, Michael F;
- Slamon, Dennis J;
- Hurvitz, Sara A;
- Curtis, Christina
The addition of HER2-targeted agents to neoadjuvant chemotherapy has dramatically improved pathological complete response (pCR) rates in early-stage, HER2-positive breast cancer. Nonetheless, up to 50% of patients have residual disease after treatment, while others are likely overtreated. Here, we performed multiplex spatial proteomic characterization of 122 samples from 57 HER2-positive breast tumors from the neoadjuvant TRIO-US B07 clinical trial sampled pre-treatment, after 14-21 d of HER2-targeted therapy and at surgery. We demonstrated that proteomic changes after a single cycle of HER2-targeted therapy aids the identification of tumors that ultimately undergo pCR, outperforming pre-treatment measures or transcriptomic changes. We further developed and validated a classifier that robustly predicted pCR using a single marker, CD45, measured on treatment, and showed that CD45-positive cell counts measured via conventional immunohistochemistry perform comparably. These results demonstrate robust biomarkers that can be used to enable the stratification of sensitive tumors early during neoadjuvant HER2-targeted therapy, with implications for tailoring subsequent therapy.