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)
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.
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.
Study Type : Interventional (Clinical Trial)- Estimated Enrollment : 600 participants
- Allocation : Randomized
- Intervention Model : Parallel Assignment
- Intervention Model Description : Participants will be randomised in a 1:1 ratio to one of two intervention groups.
- Masking : None (Open Label)
- Primary Purpose : Treatment
- Official Title : 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)
- Actual Study Start Date : May 16, 2022
- Estimated Primary Completion Date : December 3, 2025
- Estimated Study Completion Date : December 3, 2025
ClinicalTrials.gov Identifier: NCT05374512
Sponsor: AstraZeneca
Collaborator: Daiichi Sankyo, Inc.
Information provided by (Responsible Party): AstraZeneca
View this trial on clinicaltrials.gov.
What is a Clinical Trial?
A clinical trial is required by the FDA for any new therapy to come to market. It involves recruiting volunteers to help prove the therapy actually works. Every pill that you take or procedure that is performed by physicians has went through a clinical trial