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disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.\n* Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:\n\n  i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication.\n* Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.\n* No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).\n* Measurable disease by CT or MRI as per RECIST v1.1.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":3658,"type":3659},500,"ESTIMATED","INTERVENTIONAL",[3662,3663],"PHASE2","PHASE3","The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.",[3666],"Breast Neoplasms",[3668,3669,3670],"triple-negative breast cancer","antibody-drug conjugate","ER-low\u002FHER2-negative breast cancer","2026-06-09",{"date":3673,"type":3674},"2026-06-10","ACTUAL",{"date":3676,"type":3674},"2025-09-11",{"date":3678,"type":3659},"2030-05-15",{"name":5,"class":6},295]