Trastuzumab deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive metastatic Breast Cancer (DESTINY-Breast09)

Study identifier:D967UC00001

ClinicalTrials.gov identifier:NCT04784715

EudraCT identifier:2020-004074-21

CTIS identifier:N/A

Recruitment Complete

Official Title

Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

Medical condition

Breast Cancer; HER2-positive; metastatic

Phase

Phase 3

Healthy volunteers

No

Study drug

Trastuzumab deruxtecan, Placebo, Taxane, Pertuzumab, Trastuzumab

Sex

All

Actual Enrollment

1157

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 26 Apr 2021
Estimated Primary Completion Date: 24 Jul 2025
Estimated Study Completion Date: 30 Dec 2029

Study design

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

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo

Inclusion and exclusion criteria