{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["8(1)"],"submitter":["Rugo HS"],"funding":["Eli Lilly and Company","Merck"],"pubmed_abstract":["This nonrandomized, open-label, multi-cohort Phase 1b study (NCT02779751) investigated the safety and efficacy of abemaciclib plus pembrolizumab with/without anastrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) without prior CDK4 and 6 inhibitor exposure. Patients were divided into two cohorts: treatment naïve (cohort 1) and pretreated (cohort 2). Patients received abemaciclib plus pembrolizumab with (cohort 1) or without (cohort 2) anastrozole over 21-day cycles. The primary objective was safety, and secondary objectives included efficacy and pharmacokinetics (PK). Cohort 1/2 enrolled 26/28 patients, respectively. Neutropenia (30.8/28.6%), AST increase (34.6/17.9%), ALT increase (42.3/10.7%),"],"journal":["NPJ breast cancer"],"pagination":["118"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9637121"],"repository":["biostudies-literature"],"pubmed_title":["Abemaciclib in combination with pembrolizumab for HR+, HER2- metastatic breast cancer: Phase 1b study."],"pmcid":["PMC9637121"],"pubmed_authors":["Chapman SC","Kabos P","Jerusalem G","Rugo HS","Tolaney SM","Paz-Ares L","Beck JT","Wildiers H","Chisamore MJ","Hossain AM","Chen Y","Sevillano E"],"additional_accession":[]},"is_claimable":false,"name":"Abemaciclib in combination with pembrolizumab for HR+, HER2- metastatic breast cancer: Phase 1b study.","description":"This nonrandomized, open-label, multi-cohort Phase 1b study (NCT02779751) investigated the safety and efficacy of abemaciclib plus pembrolizumab with/without anastrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) without prior CDK4 and 6 inhibitor exposure. Patients were divided into two cohorts: treatment naïve (cohort 1) and pretreated (cohort 2). Patients received abemaciclib plus pembrolizumab with (cohort 1) or without (cohort 2) anastrozole over 21-day cycles. The primary objective was safety, and secondary objectives included efficacy and pharmacokinetics (PK). Cohort 1/2 enrolled 26/28 patients, respectively. Neutropenia (30.8/28.6%), AST increase (34.6/17.9%), ALT increase (42.3/10.7%),","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Nov","modification":"2026-07-14T15:57:08.386Z","creation":"2025-02-19T00:32:07.467Z"},"accession":"S-EPMC9637121","cross_references":{"pubmed":["36335120"],"doi":["10.1038/s41523-022-00482-2"]}}