NCT05113251|Active Not RecruitingPhase 3DMCFDA Drug

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)

AstraZeneca ClinicalTrials.gov

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3 other identifiers

D967RC000012023-505210-18-002021-000603-21

Study Type

interventional

Target

927

Locations

18 countries

Sites

145

Timeline

RegisteredNov 2021

StartedOct 2021

CompletionApr 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

927

participants targeted

Target at P75+ for phase_3

Timeline

12mo left

Started Oct 2021

Longer than P75 for phase_3

Geographic Reach

18 countries

145 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.5 years study duration

Study Progress82%

Oct 2021Apr 2027

First Submitted

Initial submission to the registry

October 22, 2021

Completed

3 days until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed

15 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2025

Completed

2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Expected

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

October 22, 2021

Last Update Submit

February 20, 2026

Conditions

Breast Neoplasms Breast Cancer HER2-positive Early Breast Cancer

Keywords

Trastuzumab Trastuzumab Deruxtecan (T-DXd; DS-8201a)DESTINY-BREAST11Receptor, ErbB-2breast neoplasmsAntineoplastic Agents, PhytogenicAntineoplastic Agents;Molecular Mechanisms of Pharmacological ActionDB11EnhertuHER2 (human epidermal growth factor receptor 2)breast cancer

Outcome Measures

Primary Outcomes (1)

rate of pathologic complete response (pCR)
Proportion of participants who have no evidence by H\&E staining of residual invasive disease
Up to 39 months after study start

Secondary Outcomes (3)

Event-Free Survival
Up to 72 months after study start
Invasive Disease-Free Survival (IDFS)
Up to 72 months after study start
Overall Survival
Up to 72 months after study start

Study Arms (3)

Arm A

EXPERIMENTAL

Trastuzumab deruxtecan

Drug: Trastuzumab Deruxtecan

Arm B

EXPERIMENTAL

T-DXd, followed by THP

Drug: Trastuzumab DeruxtecanDrug: PaclitaxelDrug: TrastuzumabDrug: Pertuzumab

Arm C

ACTIVE COMPARATOR

doxorubicin and cyclophosphamide, followed by THP

Drug: PaclitaxelDrug: TrastuzumabDrug: PertuzumabDrug: DoxorubicinDrug: cyclophosphamide