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)

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT05374512
Trial Phases:	Phase III	Protocol IDs:	D926PC00001 (primary) NCI-2022-05060
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT05374512

Summary

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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