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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)

NCT05629585 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1174

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dato-DXd

Experimental drug. Provided in 100mg vials. IV infusion

DRUG

Durvalumab

Experimental drug. Provided in 50mg vials. IV infusion

DRUG

Capecitabine

Active Comparator. Tablet. Oral route of administration

DRUG

Pembrolizumab

Active Comparator. Provided in 100mg vials. IV infusion

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2027-09-20
Completion
2030-01-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Puerto Rico
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629585 on ClinicalTrials.gov