...HER2-positive tumor defined as either IHC 3+ or IHC 2+, the latter in combination with ISH+, as assessed by the sponsor-designated central laboratory (pathology AMC) on a primary tumor biopsy...

...patients with human epidermal growth factor receptor 2-positive, resectable EGA...The pCR rate was significantly improved with the trastuzumab/pertuzumab treatment (A: 12%/B: 35%; P = .02). Similarly, the rate of pathologic lymph node negativity was higher with trastuzumab/pertuzumab (A: 39%/B: 68%), whereas the R0 resection rate (A: 90%/B: 93%) and surgical morbidity (A: 43%/B: 44%) were comparable....The addition of trastuzumab/pertuzumab to perioperative FLOT significantly improved pCR...

Median baseline sHER2 was 11.9 µg/ml; levels decreased in wk 4 (median 6.7 µg/ml) to return to baseline in wk 13 (median 10.9 µg/ml)...Addition of P and T to nCRT in EAC pts is feasible and has limited additional toxicity. It shows a high pCR of 33% compared to 23% after conventional nCRT and a promising 1 year PFS and OS of 85% and 90% compared to 72% and 80% after conventional nCRT, respectively.