Exploratory outcomes
HR-negative disease, intracranial lesions, HR-positive disease, Tumors
TUMORS, BRAIN METASTASIS
Though not pre-planned, exploratory analyses were conducted in a post-hoc manner. By the data cutoff date, 30 patients (75.0%, 95% CI = 58.8–87.3%) achieved clinical benefits, and the median duration of response was 15.8 months (95% CI = 7.2–28.16) among the 28 responders.In terms of subgroups, post-hoc exploratory analyses showed that ORR tended to be higher in patients with HR-negative disease (81.8% [95% CI = 59.7–94.8%], vs 55.6% [95% CI = 30.8–78.5%] in patients with HR-positive disease), and in trastuzumab-sensitive patients (80.0% [95% CI = 59.3–93.2%], vs 53.3% [95% CI = 26.6–78.7%] in trastuzumab-resistant patients; Supplementary Fig. There were 13 patients with asymptomatic brain metastasis (BM) at baseline, and 12 of them had untreated BM. The overall ORR in these 13 patients was 84.6% (95% CI = 54.6–98.1%), and the central nervous system (CNS) response rate by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 in patients with measurable intracranial lesions was 66.7% (6/9). The median PFS among all BM patients was 11.0 months (95% CI = 5.5–33.9; Supplementary Fig. 