Actively Recruiting
Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer
Led by Fundacio Clinic Barcelona · Updated on 2026-02-20
304
Participants Needed
29
Research Sites
211 weeks
Total Duration
On this page
Sponsors
F
Fundacio Clinic Barcelona
Lead Sponsor
S
SOLTI Breast Cancer Research Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedure
- Male or female patients aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Eligible for taxane, carboplatin, trastuzumab, pertuzumab, and T-DM1 therapies
- Histologically confirmed non-metastatic primary invasive breast adenocarcinoma, untreated and recently diagnosed
- Stage cT1 cN1-2 or cT2-3 cN0-2 breast cancer as per AJCC 8th edition
- Axillary lymph node status assessed by biopsy if suspected positive
- No distant metastasis (cM0)
- Multifocal tumors allowed if at least one lesion is confirmed HER2-positive
- Multicentric tumors allowed if all lesions confirmed HER2-positive
- HER2 positivity defined as IHC 3+ or HER2 2+/ISH positive per ASCO-CAP guidelines
- ER/PR status determined locally per ASCO/CAP guidelines
- Candidates for neoadjuvant treatment
- Agreement to undergo surgical management after neoadjuvant therapy
- Baseline left ventricular ejection fraction (LVEF) ≥ 50%
- Availability of good quality tumor tissue sample for HER2DX test
- Adequate hematologic and organ function
- Women of childbearing potential must agree to contraception or abstinence and avoid egg donation during and after treatment
- Men must agree to contraception or abstinence and avoid sperm donation during and after treatment
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- Known allergy to trastuzumab, pertuzumab, carboplatin, T-DM1, docetaxel, or paclitaxel
- Synchronous bilateral invasive breast cancer
- Prior systemic breast cancer therapy
- Ulcerating or inflammatory breast cancer
- Prior incisional or excisional biopsy of primary tumor or axillary nodes
- Prior sentinel lymph node or axillary dissection before neoadjuvant therapy
- History of previous breast cancer or other cancers except certain skin or cervical cancers unless in remission for at least 3 years
- Cardiopulmonary dysfunction including heart failure, uncontrolled arrhythmias, recent myocardial infarction, need for oxygen, or severe symptoms
- Major surgery within 4 weeks before study treatment or anticipated during study
- Severe infection within 4 weeks before treatment
- Significant co-morbidities affecting study participation or consent
- Pregnancy, breastfeeding, or intention to become pregnant during or shortly after treatment
- Persons under legal protection or custody
- Inability or unwillingness to comply with medical follow-up due to geographic, social, or psychological reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
MUG-Univ.-Klinik für Frauenheilkunde und Geburtshilfe, Klinische Abteilung für Gynäkologie
Graz, Austria
Actively Recruiting
2
Lkh Hochsteiermark-Leoben
Leoben, Austria
Actively Recruiting
3
Ordensklinikum Linz, Barmherzige Schwestern, Bhs
Linz, Austria
Actively Recruiting
4
Uniklinikum Salzburg
Salzburg, Austria
Actively Recruiting
5
Universitätsklinikum St.Pölten
Sankt Pölten, Austria
Actively Recruiting
6
Hanusch Krankenhaus
Vienna, Austria
Actively Recruiting
7
Klinik Hietzing, Gynäkologische Abteilung - Karl Landsteiner Institut für gyn. Onkologie
Vienna, Austria
Actively Recruiting
8
Medizinische Universität Wien, Allg. Gynäkologie und Gyn. Onkologie
Vienna, Austria
Actively Recruiting
9
Klinikum Wels-Grieskirchner
Wels, Austria
Actively Recruiting
10
Sainte-Catherine - Institut du Cancer Avignon-Provence
Avignon, France
Actively Recruiting
11
Polyclinique Bordeaux Nord
Bordeaux, France
Actively Recruiting
12
Centre León Bérard
Léon, France
Actively Recruiting
13
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
14
Institut de Cancérologie de Lorraine
Nancy, France
Actively Recruiting
15
Gustave Roussy
Paris, France
Actively Recruiting
16
Oncopole Claudius Regaud, IUCT-Oncopole
Toulouse, France
Actively Recruiting
17
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
18
Istituto Europeo di Oncologia
Milan, Italy
Actively Recruiting
19
Institute Oncology Veneto
Padova, Italy
Actively Recruiting
20
Instituto Catalán de Oncología (ICO) - Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
21
Hospital Universitario Clínico San Cecilio
Granada, Granada, Spain, 18007
Actively Recruiting
22
Hospital Clínico Universitario de Santiago
Santiago de Compostela, La Coruña, Spain, 15706
Actively Recruiting
23
Complejo Asistencial Universitario de León
León, León, Spain, 24008
Actively Recruiting
24
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
25
Hospital Clínico Universitario Virgen de Arrixaca
Murcia, Murcia, Spain, 30120
Actively Recruiting
26
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, Spain, 42301
Actively Recruiting
27
Hospital Universitario de Basurto
Bilbao, Vizcaya, Spain, 48013
Actively Recruiting
28
Instituto Catalán de Oncología (ICO) - Badalona
Badalona, Spain
Actively Recruiting
29
Hospital Universitario de Salamanca
Salamanca, Spain
Actively Recruiting
Research Team
T
Tomás Pascual, MD
CONTACT
O
Olga Martínez, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here