{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["36(31)"],"submitter":["Cruz C"],"pubmed_abstract":["<h4>Purpose</h4>This multicenter phase II trial evaluated lurbinectedin (PM01183), a selective inhibitor of active transcription of protein-coding genes, in patients with metastatic breast cancer. A unicenter translational substudy assessed potential mechanisms of lurbinectedin resistance.<h4>Patients and methods</h4>Two arms were evaluated according to germline BRCA1/2 status: BRCA1/2 mutated (arm A; n = 54) and unselected ( BRCA1/2 wild-type or unknown status; arm B; n = 35). Lurbinectedin starting dose was a 7-mg flat dose and later, 3.5 mg/m<sup>2</sup> in arm A. The primary end point was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST). The translational substudy of resistance mechanisms included exome sequencing (n = 13) and in vivo experiments "],"journal":["Journal of clinical oncology : official journal of the American Society of Clinical Oncology"],"pagination":["3134-3143"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6209089"],"repository":["biostudies-literature"],"pubmed_title":["Multicenter Phase II Study of Lurbinectedin in BRCA-Mutated and Unselected Metastatic Advanced Breast Cancer and Biomarker Assessment Substudy."],"pmcid":["PMC6209089"],"pubmed_authors":["Baselga J","Telli ML","Domchek SM","Cruz C","Soto-Matos A","Lopez R","Tung NM","Fernandez C","Kahatt C","Perez Fidalgo JA","Vahdat L","Isakoff SJ","Alfaro V","Garber JE","Llop-Guevara A","Vivancos A","Arribas J","Balmana J","Galmarini CM","Perez de la Haza A","Antolin S","Arun BK","Lluch A","Serra V"],"additional_accession":[]},"is_claimable":false,"name":"Multicenter Phase II Study of Lurbinectedin in BRCA-Mutated and Unselected Metastatic Advanced Breast Cancer and Biomarker Assessment Substudy.","description":"<h4>Purpose</h4>This multicenter phase II trial evaluated lurbinectedin (PM01183), a selective inhibitor of active transcription of protein-coding genes, in patients with metastatic breast cancer. A unicenter translational substudy assessed potential mechanisms of lurbinectedin resistance.<h4>Patients and methods</h4>Two arms were evaluated according to germline BRCA1/2 status: BRCA1/2 mutated (arm A; n = 54) and unselected ( BRCA1/2 wild-type or unknown status; arm B; n = 35). Lurbinectedin starting dose was a 7-mg flat dose and later, 3.5 mg/m<sup>2</sup> in arm A. The primary end point was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST). The translational substudy of resistance mechanisms included exome sequencing (n = 13) and in vivo experiments ","dates":{"release":"2018-01-01T00:00:00Z","publication":"2018 Nov","modification":"2025-04-04T22:21:14.78Z","creation":"2019-03-27T00:06:08Z"},"accession":"S-EPMC6209089","cross_references":{"pubmed":["30240327"],"doi":["10.1200/JCO.2018.78.6558"]}}