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NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer

NCT05704829 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2025-11-19

No results posted yet for this study

Summary

ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC.

ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC. Moreover, it aims to demonstrate excellent survival in patients treated by T-DXd (with the use of standard chemotherapy at investigator´s decision restricted only to patients with substantial residual tumour burden after T-DXd-treatment).

Conditions

  • HER2-positive Early Breast Cancer

Interventions

DRUG

Trastuzumab deruxtecan

T-DXd i.v.

DRUG

Standard-of-Care

Chemotherapy+T+P

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • West German Study Group

    lead OTHER

Principal Investigators

  • Nadia Harbeck, Prof. Dr. · Breast Centre, Dept. Obstetrics & Gynaecology and CCC Munich LMU University Hospital

  • Sherko Kuemmel, PRof. Dr. · Breast Centre, Kliniken Essen Mitte Essen

  • Oleg Gluz, PD Dr. · Breast Centre, Evang. Bethesda-Hospital Moenchengladbach

  • Michael Braun, Prof. Dr. · Breast Centre Rotkreuzklinikum Munich

  • Monika Graeser, PD Dr. · Breast Centre, Evang. Bethesda-Hospital Moenchengladbach

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2025-06-18
Completion
2029-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT05704829 on ClinicalTrials.gov