At a glance

ClinicalIndex Comparison Record

Phase 3Active· 927 enrolled / 927 target

Drug / intervention

Trastuzumab Deruxtecan +5 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05113251

NCT05113251Phase 3ActiveUpdate Overdue (16.5/mo)Completion was 15mo ago

Compare CT.gov

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·interventional·Posted Nov 9, 2021·Updated Jun 9, 2026

In Brief

A Phase 3 clinical trial evaluating Trastuzumab Deruxtecan, Paclitaxel, and 4 other interventions for Breast Neoplasms and 2 related conditions. Active but no longer recruiting, targeting 927 participants across 145 sites in 18 countries.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer

CountriesBrazil, Bulgaria, Canada, China, Germany, India, Italy, Japan, Peru, Philippines, Poland, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Thailand, United States

CollaboratorsDaiichi Sankyo

Timeline

Phase 3Active

202220232024202520262027

Enrollment StartOct 2021

First PostedNov 2021

Primary CompletionMar 2025

TodayJul 2026

Study CompletionApr 2027

First PostedNov 9, 2021

Enrollment StartOct 25, 2021

Primary CompletionMar 12, 2025

Study CompletionApr 30, 2027

TodayJul 2, 2026

Enrollment to primary: 3.4 yearsPosted 4.6 years ago

Arms & Interventions

Arm Aexperimental

Trastuzumab deruxtecan

Drug: Trastuzumab Deruxtecan

Arm Bexperimental

T-DXd, followed by THP

Drug: Trastuzumab DeruxtecanDrug: PaclitaxelDrug: TrastuzumabDrug: Pertuzumab

Arm Cactive_comparator

doxorubicin and cyclophosphamide, followed by THP

Drug: PaclitaxelDrug: TrastuzumabDrug: PertuzumabDrug: DoxorubicinDrug: cyclophosphamide