A Phase 3, multicenter, randomized, open-label, active-controlled study of trastuzumab deruxtecan (DS-8201a), an anti-HER2-antibody drug conjugate, versus ado-trastuzumab emtansine (T-DM1) for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane (DESTINY-Breast03)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511204-16-00

Acronym

DS8201-A-U302

Enrollment

Registered

2024-05-23

Start date

2019-01-23

Completion date

Unknown

Last updated

2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic breast cancer

Brief summary

The primary efficacy endpoint is PFS as determined by blinded independent central review (BICR).

Detailed description

The key secondary efficacy endpoint is OS.

Interventions

DRUGDS-8201a

DRUGKadcyla 100 mg powder for concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is PFS as determined by blinded independent central review (BICR).	—

Secondary

Measure	Time frame
The key secondary efficacy endpoint is OS.	—

Countries

Belgium, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026