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
N/A
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
Researchers are evaluating the HER2DX diagnostic assay in patients with early-stage HER2-positive breast cancer to improve how treatment decisions are made. This international phase III study compares quality of life, safety, effectiveness, and economic impact between patients receiving standard care and those receiving treatment personalized by HER2DX test results. The study focuses on patients with stage II to IIIA disease eligible for neoadjuvant therapy. Participants are randomly assigned to one of two groups: Arm A receives treatment chosen by their doctor without knowledge of HER2DX test results, following standard guidelines. Arm B receives personalized treatment based on HER2DX molecular diagnosis, which classifies patients into high-risk or low-risk groups with specific chemotherapy and antibody regimens before and after surgery. Treatments include paclitaxel, trastuzumab, pertuzumab, carboplatin, docetaxel, T-DM1, or no adjuvant therapy depending on risk and response. During the study, participants undergo assessments including quality of life questionnaires (EORTC QLQ-C30 and FACIT Fatigue Scale), cancer response evaluations, safety monitoring, and economic analyses for up to five years. Researchers will measure outcomes such as survival, cancer recurrence, adverse events, work productivity, and patient-reported health status. Participants will have surgery after neoadjuvant treatment and regular follow-ups to monitor their health and treatment effects throughout the study period.
CONDITIONS
Brief 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 obtained prior to any trial-specific 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 therapy
- Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast, untreated and recently diagnosed
- Stage cT1 cN1-2 or cT2-3 cN0-2 as per AJCC 8th edition staging
- Absence of distant metastasis (cM0)
- Multifocal or multicentric tumors allowed if HER2-positive and appropriately sampled
- HER2 positivity confirmed by IHC 3+ or HER2 2+/ ISH positive per ASCO-CAP guidelines
- ER/PR status determined locally according to ASCO/CAP guidelines
- Candidates for neoadjuvant treatment
- Agreement to undergo appropriate surgery after neoadjuvant treatment
- Baseline left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or MUGA
- Availability of suitable pre-treatment tumor tissue sample for HER2DX test
- Adequate hematologic and organ function
- Agreement to use effective contraception or abstinence as defined if of childbearing potential
- For men, agreement to use contraception or abstinence with partners as defined
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- Known hypersensitivity to trastuzumab, pertuzumab, carboplatin, T-DM1, docetaxel, or paclitaxel excipients
- Synchronous bilateral invasive breast cancer
- Prior systemic therapy for breast cancer
- Ulcerating or inflammatory breast cancer
- Prior incisional or excisional biopsy of primary tumor or axillary lymph nodes
- Prior sentinel lymph node procedure or axillary lymph node dissection before neoadjuvant therapy
- History of previous breast cancer or other cancers (except certain cases) within 3 years
- Cardiopulmonary dysfunction, including heart failure, serious arrhythmias, or recent myocardial infarction
- Major surgery within 4 weeks before study treatment or planned during study
- Severe infection within 4 weeks before study treatment
- Significant co-morbidities interfering with study participation
- Pregnancy, breastfeeding, or intention to become pregnant during treatment and defined periods after
- Persons under protective custody or guardianship
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to neoadjuvant treatment duration plus adjuvant treatment cycles (varies between 12 to 18 weeks for neoadjuvant and up to 14 cycles of adjuvant therapy)
Participants receive personalized treatment based on molecular diagnosis with HER2DX or standard treatment by physician's choice blinded to HER2DX results. Neoadjuvant treatment includes chemotherapy and HER2 blockade, followed by surgery. Adjuvant treatment depends on pathological response at surgery and risk classification.
Multiple visits for treatment administration and monitoring as per treatment cycles
Duration - Up to 5 years
Participants are followed for up to 5 years to assess quality of life, treatment safety, efficacy outcomes, and economic impact.
Periodic visits over 5 years for assessments and questionnaires
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
O
Olga Martínez, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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