A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

Titre officiel

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)

Sommaire:

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

Description de l'essai

Primary Outcome:

• Progression Free Survival (PFS)
• Overall Survival (OS)

Secondary Outcome:

• Objective Response Rate (ORR)
• Duration of Response (DoR)
• Progression-Free Survival (PFS) by Investigator assessment
• Time to deterioration (TTD) in pain in participants treated with Dato DXd compared with ICC
• Time to deterioration (TTD) in physical functioning in participants treated with Dato DXd compared with ICC
• Time to deterioration (TTD) in breast and arm symptoms in participants treated with Dato DXd compared to ICC
• Time to deterioration (TTD) in GHS/QoL in participants treated with Dato DXd compared with ICC
• Time to First Subsequent Therapy (TFST)
• Time to Second Subsequent Therapy (TSST)
• Progression Free Survival 2 (PFS2)
• Pharmacokinetics of Dato-DXd
• Immunogenicity of Dato-DXd
• Safety of Dato-DXd

The primary objectives of the study are 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 and 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.

Voir cet essai sur ClinicalTrials.gov