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Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer

NCT05900206 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2025-09-02

No results posted yet for this study

Summary

The goal of this clinical trial is to compare trastuzumab deruxtecan (T-DXd) to standard preoperative treatment in patients with non-metastatic HER2-positive breast cancer. The main questions it aims to answer are:

* is T-DXd more effective than standard preoperative treatment?
* are there markers in the tumor or blood of patients with HER2-positive breast cancer that can help us predict response to treatment?

Participants will be divided into two groups, where one group will be treated with three courses of T-DXd and the other group will be treated with three courses standard of care treatment. Thereafter, further treatment will be decided by the tumor's molecular subtype.

Conditions

Interventions

DRUG

Trastuzumab deruxtecan

Experimental drug. Provided in 100mg vials. IV infusion.

DRUG

Docetaxel

Active comparator. IV infusion.

DRUG

Paclitaxel

Active comparator. IV infusion.

DRUG

Carboplatin

Active comparator. IV infusion.

DRUG

Trastuzumab

Active comparator. IV infusion.

DRUG

Pertuzumab

Active comparator. IV infusion.

DRUG

Ribociclib

Experimental drug. Tablets.

DRUG

Letrozole

Experimental drug. Tablets.

DRUG

Epirubicin

Active comparator. IV infusion.

DRUG

Cyclophosphamide

Active comparator. IV infusion.

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Theodoros Foukakis, MD/PhD · Karolinska University Hospital

  • Alexios Matikas, MD/PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-26
Primary Completion
2027-04-30
Completion
2032-04-30

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

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 NCT05900206 on ClinicalTrials.gov