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Trastuzumab Deruxtecan (T-DXd...

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

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

927 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2027-04-30

Brief Summary

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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.

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Detailed Description

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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

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Breast Neoplasms Breast Cancer HER2-positive Early Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to one of three arms in parallel for the duration of the study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Trastuzumab deruxtecan

Group Type EXPERIMENTAL