Objective:
Primary Objectives:
To demonstrate superiority of Dato-DXd relative to ICC by assessment of PFS in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy, per BICR.
To demonstrate superiority of Dato-DXd relative to ICC by assessment of OS in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy
Secondary Objectives:
To demonstrate superiority of Dato-DXd relative to ICC by assessment of ORR in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy, per BICR and per investigator assessment.
To demonstrate the superiority of Dato-DXd relative to ICC by assessment of DoR in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy, per BICR and per investigator assessment.
To demonstrate the superiority of Dato-DXd relative to ICC by assessment of PFS as assessed by the investigator in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
To demonstrate the superiority of Dato-DXd relative to ICC by assessment of DCR in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy, per BICR and per investigator assessment.
To assess TTD in pain in participants treated with Dato-DXd compared with ICC.
To assess TTD in physical functioning in participants treated with Dato-DXd compared with ICC.
To assess TTD in breast and arm symptoms in participants treated with Dato-DXd compared to ICC.
To assess TTD in GHS/QoL in participants treated with Dato-DXd compared with ICC.
To demonstrate the superiority of Dato-DXd relative to ICC by assessment of TFST in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
To demonstrate the superiority of Dato-DXd relative to ICC by assessment of TSST in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
To demonstrate the superiority of Dato-DXd relative to ICC by assessment of PFS2 in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
To assess the pharmacokinetics of Dato-DXd 6.0 mg/kg IV Q3W.
To investigate the immunogenicity of Dato-DXd 6.0 mg/kg IV Q3W.