A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT05629585
Trial Phases:	Phase III	Protocol IDs:	D926XC00001 (primary) NCI-2023-00614 2022-002680-30
Eligibility:	18 - 130 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT05629585

Summary

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study
assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with
ICT in participants with stage I to III TNBC with residual invasive disease in the breast
and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

Objectives

The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab
when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I
to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes
at surgical resection following neoadjuvant systemic therapy.

The primary objective of the study is to demonstrate superiority of Dato-DXd in
combination with durvalumab relative to ICT by assessment of iDFS in participants with
stage I to III TNBC with residual invasive disease at surgical resection following
neoadjuvant 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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