RecruitingPhase 2NCT05900206

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

A Randomized Trial of Trastuzumab Deruxtecan and Biology-Driven Selection of Neoadjuvant Treatment for HER2-positive Breast Cancer: ARIADNE


Sponsor

Karolinska University Hospital

Enrollment

370 participants

Start Date

Oct 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new targeted antibody-drug therapy (trastuzumab deruxtecan) to the current standard chemotherapy regimen given before surgery in people with HER2-positive breast cancer. HER2-positive means the cancer has a protein on its surface that fuels its growth. **You may be eligible if...** - You are 18 or older (men or women) - You have HER2-positive breast cancer confirmed by tissue testing - Your tumor is at least 20mm, or your cancer has spread to nearby lymph nodes - You have not yet received treatment for this breast cancer - Your general health is good (ECOG status 0 or 1) **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (metastatic) - You have significant heart, liver, or lung problems - You are pregnant or breastfeeding - You have previously received certain cancer treatments that would exclude you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab deruxtecan

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

DRUGDocetaxel

Active comparator. IV infusion.

DRUGPaclitaxel

Active comparator. IV infusion.

DRUGCarboplatin

Active comparator. IV infusion.

DRUGTrastuzumab

Active comparator. IV infusion.

DRUGPertuzumab

Active comparator. IV infusion.

DRUGRibociclib

Experimental drug. Tablets.

DRUGLetrozole

Experimental drug. Tablets.

DRUGEpirubicin

Active comparator. IV infusion.

DRUGCyclophosphamide

Active comparator. IV infusion.


Locations(7)

Skåne University Hospital

Malmö, Sweden

Örebro University Hospital

Örebro, Sweden

Sankt Gorans Hospital

Stockholm, Sweden

Stockholm Southern Hospital

Stockholm, Sweden

Karolinska University Hospital

Stockholm, Sweden

Norrlands University Hospital

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden

View Full Details on ClinicalTrials.gov

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NCT05900206


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