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NCT Number: NCT06723990

Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX

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.

Recruiting

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Key information

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Neoadjuvant standard treatment for HER2+

Drug

NEOADJUVANT SETTING

Adjuvant standard treatment for HER2+

Drug

ADJUVANT SETTING

Primary outcomes

  1. Impact of HER2DX on the decision-making processes of the treating physicians and multidisciplinary tumour board, in patients with stage I-III HER2+ BC

    Time frame: from baseline to the end of treatment at 12 month

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Paola Zagami

CONTACT

[email protected]

00390294372437

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Acronym: HER2BREASTDX

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2024
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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