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

NCT ID: NCT06723990

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-24

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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HER2 positive breast cancer patients with stage I-III

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NEOADJUVANT SETTING

Neoadjuvant standard treatment for HER2+: A→Tax +T/P

Neoadjuvant standard treatment for HER2+

Intervention Type DRUG

NEOADJUVANT SETTING

ADJUVANT SETTING

Adjuvant standard treatment for HER2+ (N0): Tax + T (+/-ET); Adjuvant standard treatment for HER2+ (N+): A→Tax +T/P (+/- ET)

Adjuvant standard treatment for HER2+

Intervention Type DRUG

ADJUVANT SETTING

Interventions

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Neoadjuvant standard treatment for HER2+

NEOADJUVANT SETTING

Intervention Type DRUG

Adjuvant standard treatment for HER2+

ADJUVANT SETTING

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Criscitiello

Role: PRINCIPAL_INVESTIGATOR

Istituto Europeo di Oncologia

Locations

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Istituto Europeo di Oncologia

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Carmen Criscitiello

Role: CONTACT

Phone: 00390294372689

Email: [email protected]

Beatrice Taurelli Salimbeni

Role: CONTACT

Phone: 00390294372035

Email: [email protected]

Facility Contacts

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Carmen Criscitiello

Role: primary

Other Identifiers

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UID 4259

Identifier Type: -

Identifier Source: org_study_id