biostudies-literatureUnknownSideras KPublic Health ServiceNCI NIH HHSNational Cancer Institute Department of Health and Human Services<h4>Background</h4>Anthracycline use in metastatic breast cancer (MBC) is hindered by cumulative exposure limits and risk of cardiotoxicity. Pixantrone, a novel aza-anthracenedione with structural similarities to mitoxantrone and anthracyclines, is theorized to exhibit less cardiotoxicity, mainly due to lack of iron binding. We conducted a randomized phase II study to evaluate the efficacy and safety of 2 dosing schedules of pixantrone in patients with refractory HER2-negative MBC.<h4>Methods</h4>Intravenous pixantrone was administered at 180 mg/m2 every 3 weeks (group A) versus 85 mg/m2 on days 1, 8, and 15 of a 28-day cycle (group B). Primary endpoint was objective response rate (ORR) and secondary endpoints included progression-free survival (PFS), median 6-month PFS, overall survival (The oncologistoyab065https://www.ebi.ac.uk/biostudies/studies/S-EPMC9074972biostudies-literatureRandomized Phase II Study of Two Doses of Pixantrone in Patients with Metastatic Breast Cancer (NCCTG N1031, Alliance).PMC9074972U10 CA180882P30 CA015083U10 CA180821U10CA025224UG1 CA232760U10CA180821Liu HDueck ACMowat RBGiridhar KPerez EAMoreno-Aspitia ATenglin RCChen BSideras KGross GGGinos BFTan WHillman DWfalseRandomized Phase II Study of Two Doses of Pixantrone in Patients with Metastatic Breast Cancer (NCCTG N1031, Alliance).<h4>Background</h4>Anthracycline use in metastatic breast cancer (MBC) is hindered by cumulative exposure limits and risk of cardiotoxicity. Pixantrone, a novel aza-anthracenedione with structural similarities to mitoxantrone and anthracyclines, is theorized to exhibit less cardiotoxicity, mainly due to lack of iron binding. We conducted a randomized phase II study to evaluate the efficacy and safety of 2 dosing schedules of pixantrone in patients with refractory HER2-negative MBC.<h4>Methods</h4>Intravenous pixantrone was administered at 180 mg/m2 every 3 weeks (group A) versus 85 mg/m2 on days 1, 8, and 15 of a 28-day cycle (group B). Primary endpoint was objective response rate (ORR) and secondary endpoints included progression-free survival (PFS), median 6-month PFS, overall survival (2022-01-01T00:00:00Z2022 Apr2025-04-04T10:02:26.696Z2025-04-04T10:02:26.696ZS-EPMC90749723544572310.1093/oncolo/oyab065