{"doi":"10.1007/s10549-024-07555-9","title":"Pexidartinib and standard neoadjuvant therapy in the adaptively randomized I-SPY2 trial for early breast cancer","abstract":"PURPOSE: We investigated the small-molecule receptor tyrosine kinase-inhibitor of colony-stimulating factor-1 receptor pexidartinib in the stage II/III breast cancer in the I-SPY2 platform trial. METHODS: I-SPY2 is an adaptive platform trial that features multiple arms of experimental agents administered on a background of standard neoadjuvant therapy with paclitaxel and adriamycin/cyclophosphamide, followed by definitive surgery. The adaptive randomization engine preferentially assigns patients based upon cumulative performance of each agent in a given breast cancer subtype based on hormone receptor and HER2 receptor status. The study endpoint is pathologic complete response. RESULTS: A total of 9 participants were randomized to receive pexidartinib with neoadjuvant paclitaxel before enrollment was halted due to a serious adverse event of vanishing bile duct syndrome. No participants received a full course of the study drug. CONCLUSION: Although there remains interest in agents targeting CSF-1, hepatic toxicity appears to be a limiting factor for their use in early breast cancer. TRIAL REGISTRATION: NCT01042379 ( www. CLINICALTRIALS: gov/ct2/show/NCT01042379 ).","journal":"Breast Cancer Research and Treatment","year":2024,"id":451082,"datarank":0.25483989605356555,"base_score":1.6094379124341003,"endowment":1.6094379124341003,"self_citation_contribution":0.24141568686511508,"citation_network_contribution":0.013424209188450446,"self_endowment_contribution":0.24141568686511508,"citer_contribution":0.013424209188450446,"corpus_percentile":null,"corpus_rank":null,"citation_count":4,"citer_count":4,"citers_with_citation_signal":2,"citers_with_endowment":2,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.956,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT01042379"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1272523,"name":"Mike Campbell","orcid":null,"position":1,"is_corresponding":false},{"id":14257,"name":"Christina Yau","orcid":"0000-0002-1937-0859","position":2,"is_corresponding":false},{"id":228238,"name":"A. 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