RecruitingNot applicableEN originalBreast cancerHER2 positiveEarly / localized

Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

The primary goal of the DEFINITIVE trial is to demonstrate the effectiveness of the HER2DX diagnostic assay in enhancing the management of patients with early-stage HER2- positive breast cancer. Patients randomized to arm A will receive adjuvant treatment by physician´s choice, blinded to the diagnostic HER2DX test results. Patients randomized to Arm B will receive personalized treatment according to HER2DX results.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjent ma co najmniej 18 lat i wyraził zgodę na udział.
  • Ogólny stan zdrowia pacjenta pozwala na leczenie.
  • Rak piersi jest potwierdzony badaniem tkanki, nie jest zaawansowany (nie ma przerzutów w inne miejsca ciała).
  • Wyniki badań wskazują na obecność receptora HER2 (HER2-dodatni rak).
  • Guzy w piersiach mogą być pojedyncze lub mnogie (w tym w różnych częściach piersi), pod warunkiem, że będą przebadane i okażą się HER2-dodatnie.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
February 20, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (29)

MUG-Univ.-Klinik für Frauenheilkunde und Geburtshilfe, Klinische Abteilung für Gynäkologie

Graz, Austria

Lkh Hochsteiermark-Leoben

Leoben, Austria

Ordensklinikum Linz, Barmherzige Schwestern, Bhs

Linz, Austria

Uniklinikum Salzburg

Salzburg, Austria

Universitätsklinikum St.Pölten

Sankt Pölten, Austria

Hanusch Krankenhaus

Vienna, Austria

Klinik Hietzing, Gynäkologische Abteilung - Karl Landsteiner Institut für gyn. Onkologie

Vienna, Austria

Medizinische Universität Wien, Allg. Gynäkologie und Gyn. Onkologie

Vienna, Austria

Klinikum Wels-Grieskirchner

Wels, Austria

Sainte-Catherine - Institut du Cancer Avignon-Provence

Avignon, France

Polyclinique Bordeaux Nord

Bordeaux, France

Centre León Bérard

Léon, France

Institut Paoli Calmettes

Marseille, France

Institut de Cancérologie de Lorraine

Nancy, France

Gustave Roussy

Paris, France

Oncopole Claudius Regaud, IUCT-Oncopole

Toulouse, France

Sheba Medical Center

Ramat Gan, Israel

Istituto Europeo di Oncologia

Milan, Italy

Institute Oncology Veneto

Padova, Italy

Instituto Catalán de Oncología (ICO) - Hospitalet

L'Hospitalet de Llobregat, Spain

Hospital Universitario Clínico San Cecilio

Granada, Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

Complejo Asistencial Universitario de León

León, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Clínico Universitario Virgen de Arrixaca

Murcia, Spain

Hospital Universitario Sant Joan de Reus

Reus, Spain

Hospital Universitario de Basurto

Bilbao, Spain

Instituto Catalán de Oncología (ICO) - Badalona

Badalona, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Trial contact

Olga Martínez, MD

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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