NCT05900206

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-26
• Primary completion: 2027-04-30
• Completion: 2032-04-30
• First posted: 2023-06-12
• Last updated: 2025-09-02

Locations

7 sites across 1 country: Sweden