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

NCT05113251 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 927

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2025-03-12
Completion
2027-04-30
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05113251 on ClinicalTrials.gov