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)

Study identifier:D926PC00001

ClinicalTrials.gov identifier:NCT05374512

EudraCT identifier:2021-005223-21

CTIS identifier:N/A

Recruitment Complete

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)

Medical condition

Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Dato-DXd, Paclitaxel, Nab-paclitaxel, Carboplatin, Capecitabine, Eribulin mesylate

Sex

All

Actual Enrollment

637

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 16 May 2022
Estimated Primary Completion Date: 03 Dec 2025
Estimated Study Completion Date: 03 Dec 2025

Study design

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

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo

Inclusion and exclusion criteria