NCT05113251

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 927 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

Detailed description

The target population of interest in this study is participants with high-risk HER2-positive early-stage breast cancer. The purpose of this study is to determine the efficacy and safety of T-DXd neoadjuvant therapy. Participants will be randomised to one of 3 arms: T-DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C).

Conditions

• Breast Neoplasms
• Breast Cancer
• HER2-positive Early Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab Deruxtecan	administered by intravenous infusion
DRUG	Paclitaxel	administered by intravenous infusion
DRUG	Trastuzumab	administered by intravenous infusion
DRUG	Pertuzumab	administered by intravenous infusion
DRUG	Doxorubicin	administered by intravenous infusion
DRUG	cyclophosphamide	administered by intravenous infusion

Timeline

• Start date: 2021-10-25
• Primary completion: 2025-03-12
• Completion: 2027-04-30
• First posted: 2021-11-09
• Last updated: 2026-02-23

Locations

145 sites across 18 countries: United States, Brazil, Bulgaria, Canada, China, Germany, India, Italy, Japan, Peru, Philippines, Poland, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated drug study