Evaluating HER2DX's impact on treatment decisions for early stage HER2+ breast cancer
Prospective Observational Monocentric Study to Evaluate the Impact of the HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2-BREAST-DX
European Institute of Oncology · NCT06723990
This study is testing how the HER2DX test affects treatment choices for patients with early stage HER2+ breast cancer to see if it helps doctors feel more confident in their recommendations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology (other) |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06723990 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how the HER2DX assay influences treatment decisions made by physicians for patients with early stage HER2+ breast cancer. It focuses on the decision-making processes within multidisciplinary tumor boards, particularly regarding the type and setting of systemic therapy. The study will evaluate the confidence of clinicians in their treatment recommendations based on the HER2DX results. Patients eligible for neoadjuvant or adjuvant therapy will be included, and informed consent will be required for participation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed HER2+ breast cancer at stages I-III.
Not a fit: Patients with HER2- breast cancer or those with stage IV breast cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment decision-making for patients with early stage HER2+ breast cancer, potentially leading to more personalized and effective therapies.
How similar studies have performed: Other studies have shown promising results in using molecular assays to guide treatment decisions in breast cancer, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years of age; * Histologically confirmed HER2+ breast cancer; * Stage I-III breast cancer without evidence of distant metastases; * Being candidate to neoadjuvant/adjuvant therapy and locoregional treatment (surgery +/- radiotherapy); * Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients); Exclusion Criteria: * HER2- BC; * Stage IV breast cancer; * Lack of informed consent because of patient's incapable of discernment or unwilling to participate;
Where this trial is running
Milan, Italy
- Istituto Europeo di Oncologia — Milan, Italy, Italy (RECRUITING)
Study contacts
- Principal investigator: Paola Zagami — Istituto Europeo di Oncologia
- Study coordinator: Paola Zagami
- Email: paola.zagami@ieo.it
- Phone: 00390294372437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Early Stage Breast Cancer, HER2 positive breast cancer patients with stage I-III