Patient allocation and baseline characteristics
HER2 GENE AMPLIFICATION, MAY, RECRUITMENT
Between April 9, 2020, and May 19, 2021, a total of 42 patients were screened and 41 were enrolled and received study treatment. As per protocol, 24 patients were enrolled in the first stage and 17 responses were achieved, reaching the prespecified target for this stage, so the recruitment continued. One patient’s updated information showed that she had a HER2 immunohistochemistry (IHC) score of 1+ and HER2 gene amplification by fluorescence in-situ hybridization (FISH), which did not meet the inclusion criteria. Thus, the patient was excluded from the efficacy analysis though she received study treatment (Fig. 