Asset profile
H3B-6545
Small molecule
Evidence outlook · lead readout
NCT03250676 · Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast, Breast Cancer Female, Breast Adenocarcinoma, Estrogen Receptor Positive Tumor, ER Positive
The reported results come from study designs that frequently fail to replicate under controlled conditions — see the rationale below.
NCT03250676: This was a non-randomized, open-label study with no placebo or active-control group; 151 participants received H3B-6545 across dose-escalation and dose-expansion cohorts. Its primary outcomes were descriptive, including radiologic objective response, and there was no formal controlled comparison to determine whether the primary endpoint was met.
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