NCT06723990 Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
| NCT ID | NCT06723990 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Breast Cancer Early Stage Breast Cancer (Stage 1-3) |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-10-24 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.
Eligibility 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;
Contact & Investigator
Paola Zagami
PRINCIPAL INVESTIGATOR
Istituto Europeo di Oncologia
Frequently Asked Questions
Who can join the NCT06723990 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer Early Stage Breast Cancer (Stage 1-3). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06723990 currently recruiting?
Yes, NCT06723990 is actively recruiting participants. Contact the research team at paola.zagami@ieo.it for enrollment information.
Where is the NCT06723990 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06723990 clinical trial?
NCT06723990 is sponsored by European Institute of Oncology. The principal investigator is Paola Zagami at Istituto Europeo di Oncologia. The trial plans to enroll 60 participants.
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