{"doi":"10.1007/s10549-014-3238-6","title":"Phase II, multicenter, open-label, randomized study of YM155 plus docetaxel as first-line treatment in patients with HER2-negative metastatic breast cancer","abstract":null,"journal":"Breast Cancer Research and Treatment","year":2015,"id":612668,"datarank":0.6573039952010823,"base_score":4.382026634673881,"endowment":4.382026634673881,"self_citation_contribution":0.6573039952010823,"citation_network_contribution":0.0,"self_endowment_contribution":0.6573039952010823,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":79,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1577626,"name":"Oleg A. Gladkov","orcid":null,"position":1,"is_corresponding":false},{"id":1577627,"name":"Elaina Gartner","orcid":null,"position":2,"is_corresponding":false},{"id":1577628,"name":"Vladimir Vladimirov","orcid":null,"position":3,"is_corresponding":false},{"id":1016128,"name":"John Crown","orcid":"0000-0002-3125-7613","position":4,"is_corresponding":false},{"id":1577629,"name":"Joyce Steinberg","orcid":null,"position":5,"is_corresponding":false},{"id":1577630,"name":"Fei Jie","orcid":null,"position":6,"is_corresponding":false},{"id":1577631,"name":"Anne Keating","orcid":null,"position":7,"is_corresponding":false},{"id":1577625,"name":"Michael R. Clemens","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Phase II, multicenter, open-label, randomized study of YM155 plus docetaxel as first-line treatment in patients with HER2-negative metastatic breast cancer","abstract":"The objective of this study was to assess the efficacy and tolerability of YM155, a survivin suppressor, in combination with docetaxel, compared with docetaxel alone in patients with HER2-negative metastatic breast cancer. This phase II, multicenter, open-label, 2-arm study randomized patients (≥18 years) with histologically or cytologically confirmed stage IV HER2-negative metastatic breast cancer and ≥1 measurable lesion, to receive docetaxel alone or docetaxel plus YM155. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), time to response (TTR), biomarker assessment, and analysis of circulating tumor cells. Patients were women diagnosed with HER2-negative breast cancer; most had received prior drug therapies. The median PFS was 8.4 months with YM155 plus docetaxel (n = 50) and 10.5 months with docetaxel alone (n = 51; HR 1.53; 95 % CI 0.83, 2.83; P = 0.176). No statistically significant differences were observed for secondary endpoints, although slightly greater OS (630 vs 601 days; P = 0.768), CBR (84.3 vs 82.0 %; P = 0.855), DOR, and TTR were observed with docetaxel alone compared with YM155 plus docetaxel, whereas ORR was similar (25.5 vs 26.0). The most common TEAEs observed with YM155 plus docetaxel compared with docetaxel alone were neutropenia (83.3 vs 84.3 %), alopecia (62.5 vs 52.9 %), fatigue (50 vs 41.2 %), and nausea (37.5 vs 41.2 %). Although YM155 is a novel drug that suppresses survivin, YM155 plus docetaxel exhibited no statistically significant differences in endpoints compared with docetaxel alone. The combination regimen was well tolerated.","is_dataset_classified":null,"base_score":4.382026634673881,"endowment":4.382026634673881,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"25547219","pmcid":"PMC4298663","openalex_id":"https://openalex.org/W1971162671","authors":[],"funders":[],"total_grants":0,"fwci":2.899,"citation_percentile":0.92211016,"influential_citations":0,"citation_trend":[{"year":2014,"count":1},{"year":2015,"count":2},{"year":2016,"count":9},{"year":2017,"count":9},{"year":2018,"count":13},{"year":2019,"count":8},{"year":2020,"count":7},{"year":2021,"count":7},{"year":2022,"count":9},{"year":2023,"count":5},{"year":2024,"count":1},{"year":2025,"count":5},{"year":2026,"count":3}],"oa_status":"hybrid","license":"cc-by-nc","oa_locations":[{"url":"https://link.springer.com/content/pdf/10.1007/s10549-014-3238-6.pdf","host_type":"journal"},{"url":"https://link.springer.com/content/pdf/10.1007/s10549-014-3238-6.pdf","host_type":"publisher"},{"url":"http://link.springer.com/content/pdf/10.1007/s10549-014-3238-6.pdf","host_type":"publisher"},{"url":"http://link.springer.com/article/10.1007/s10549-014-3238-6/fulltext.html","host_type":"publisher"},{"url":"http://link.springer.com/content/pdf/10.1007/s10549-014-3238-6","host_type":"publisher"},{"url":"https://doi.org/10.1007/s10549-014-3238-6","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/25547219","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4298663","host_type":"repository"},{"url":"https://europepmc.org/articles/PMC4298663","host_type":"Europe_PMC"},{"url":"https://europepmc.org/articles/PMC4298663?pdf=render","host_type":"Europe_PMC"}],"fields_of_study":["HER2/EGFR in Cancer Research","Cancer Treatment and Pharmacology","Lung Cancer Treatments and Mutations"],"mesh_terms":["Docetaxel","Adult","Aged","Antineoplastic Combined Chemotherapy Protocols","Breast Neoplasms","Female","Humans","Imidazoles","Lymphatic Metastasis","Middle Aged","Naphthoquinones","Treatment Outcome","Disease-Free Survival","Receptor, ErbB-2","Erb-b2 Receptor Tyrosine Kinases","Taxoids","Drug-Related Side Effects and Adverse Reactions"],"keywords":["Docetaxel","Medicine","Metastatic breast cancer","Tolerability","Breast cancer","Internal medicine","Oncology","Clinical endpoint","Neutropenia","Phases of clinical research","Cancer","Gastroenterology","Chemotherapy","Clinical trial","Adverse effect"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-02T04:29:44.436651Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}