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)

Study identifier:D926XC00001

ClinicalTrials.gov identifier:NCT05629585

EudraCT identifier:2022-002680-30

CTIS identifier:N/A

Recruiting

Official Title

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients with Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

Medical condition

Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Dato-DXd, Durvalumab, Capecitabine, Pembrolizumab

Sex

All

Estimated Enrollment

1075

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 28 Nov 2022
Estimated Primary Completion Date: 20 Sept 2027
Estimated Study Completion Date: 27 Mar 2030

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo, Inc, SWOG Clinical Trials Partnerships

Inclusion and exclusion criteria