NCT05900206: ARIADNE

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

Recruiting now Phase 2 Last updated 2 September 2025

What this trial tests

Phase 2 trial testing Trastuzumab deruxtecan in Breast Cancer in 370 participants. Currently enrolling.

Timeline

26 October 2023

Primary endpoint
30 April 2027

30 April 2032

Quick facts

Lead sponsor	Karolinska University Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	370
Start date	26 October 2023
Primary completion	30 April 2027
Estimated completion	30 April 2032
Sites	7 locations across Sweden

Drugs / interventions tested

• Trastuzumab deruxtecan — full drug profile →
• Docetaxel
• Paclitaxel — full drug profile →
• Carboplatin
• Trastuzumab
• Pertuzumab
• Ribociclib
• Letrozole — full drug profile →
• Epirubicin (EPIRUBICIN) — full drug profile →
• Cyclophosphamide

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Karolinska University Hospital

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mechanisms of action and resistance to anti-HER2 antibody-drug conjugates in breast cancer.
   Saleh K, Khoury R, Khalife N, Chahine C, et al · · 2024 · cited 27× · PMID 39050884 · DOI 10.20517/cdr.2024.06
2. Tailoring Neoadjuvant Therapy in Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: Recent Advances and Strategies.
   Esteva FJ, Katz E. · · 2024 · cited 11× · PMID 38471052 · DOI 10.1200/op.23.00563
3. Advances in the study of marketed antibody-drug Conjugates (ADCs) for the treatment of breast cancer.
   Liang Y, Zhang P, Li F, Lai H, et al · · 2023 · cited 10× · PMID 38352694 · DOI 10.3389/fphar.2023.1332539
4. Novel HER-2 Targeted Therapies in Breast Cancer.
   Fernandes CL, Silva DJ, Mesquita A. · · 2023 · cited 9× · PMID 38201515 · DOI 10.3390/cancers16010087
5. Novel treatment approaches utilizing antibody-drug conjugates in breast cancer.
   Davis AA, Hesse J, Pereira PMR, Ma CX. · · 2025 · cited 8× · PMID 40360516 · DOI 10.1038/s41523-025-00743-w
6. A population-based study on trajectories of HER2 status during neoadjuvant chemotherapy for early breast cancer and metastatic progression.
   Boman C, Liu X, Eriksson Bergman L, Sun W, et al · · 2024 · cited 7× · PMID 38942987 · DOI 10.1038/s41416-024-02777-6
7. Docetaxel Resistance in Breast Cancer: Current Insights and Future Directions.
   Postigo-Corrales F, Beltrán-Videla A, Lázaro-Sánchez AD, Hurtado AM, et al · · 2025 · cited 5× · PMID 40806254 · DOI 10.3390/ijms26157119
8. Navigating antibody‒drug conjugates (ADCs): from metastatic to early breast cancer treatment strategies.
   Najdi T, Awad L, Chartouni A, Soueidy C, et al · · 2025 · cited 5× · PMID 40304863 · DOI 10.1007/s10637-025-01525-8