Trastuzumab deruxtecan (T-DXd) alone or in sequence with THP, versus standard treatment (ddAC-THP), in HER2-positive early breast cancer

Study identifier:D967RC00001

ClinicalTrials.gov identifier:NCT05113251

EudraCT identifier:2021-000603-21

CTIS identifier:N/A

Recruiting

Official Title

A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)

Medical condition

Breast Neoplasms

Phase

Phase 3

Healthy volunteers

No

Study drug

Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab, Pertuzumab, Doxorubicin, cyclophosphamide

Sex

All

Estimated Enrollment

900

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 25 Oct 2021
Estimated Primary Completion Date: 20 Dec 2024
Estimated Study Completion Date: 30 Apr 2027

Study design

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

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi-Sankyo

Inclusion and exclusion criteria