RecruitingNot ApplicableNCT06446882

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

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

Sponsor

Fundacio Clinic Barcelona

Enrollment

304 participants

Start Date

Oct 11, 2024

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a diagnostic test called HER2DX — a genomic test that scores how aggressive a HER2-positive breast cancer is — to guide whether patients need the full intensity of standard treatment or whether some chemotherapy can be safely reduced. The goal is to personalize treatment and spare low-risk patients from unnecessary side effects. **You may be eligible if...** - You are 18 or older with a confirmed new diagnosis of HER2-positive, non-metastatic invasive breast cancer - Your cancer is staged as cT1 cN1-2 or cT2-3 cN0-2 (early-stage, potentially with lymph node involvement) - You have not yet received any treatment for this cancer - You are in reasonably good health (ECOG 0–2) and eligible for standard HER2-targeted drugs **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have had a previous breast cancer - You are pregnant or breastfeeding 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

DEVICEPersonalized treatment according to molecular diagnosis with HER2DX

Patients with HER2DX high-risk disease: * Neoadjuvant treatment: * High HER2DX pCR score: paclitaxel per 12 weeks + trastuzumab +/- pertuzumab per 4-5 cycles. * Medium HER2DX pCR score: carboplatin + paclitaxel per 12-18 (or docetaxel per 4-6 cycles) + trastuzumab +/- pertuzumab per 4-7 cycles. * Low HER2DX pCR score: standard of care neoadjuvant CT regimens and HER2 blockade at the investigator's choice. * Adjuvant treatment: * pCR at surgery; Trastuzumab +/- pertuzumab up to a total of 18 cycles (including neoadjuvant and adjuvant therapy). * No pCR at surgery: T-DM1 per 14 cycles. Patients with HER2DX low-risk disease: * Neoadjuvant treatment: paclitaxel per 12 weeks + trastuzumab +/- pertuzumab per 4-5 cycles. * Adjuvant treatment will be according to the pCR status at surgery: * pCR at surgery: trastuzumab or no adjuvant treatment. * No pCR at surgery: trastuzumab or T-DM1.

OTHERTreatment by physician´s choice, blinded to the diagnostic HER2DX test results

Patients randomized in ARM A will be treated with standard of care neoadjuvant CT regimens and HER2 blockade at the investigator's choice validated by national and/or international guidelines.

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, Barcelona, Spain

Hospital Universitario Clínico San Cecilio

Granada, Granada, Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Complejo Asistencial Universitario de León

León, León, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital Clínico Universitario Virgen de Arrixaca

Murcia, Murcia, Spain

Hospital Universitario Sant Joan de Reus

Reus, Tarragona, Spain

Hospital Universitario de Basurto

Bilbao, Vizcaya, Spain

Instituto Catalán de Oncología (ICO) - Badalona

Badalona, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

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NCT06446882

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