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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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);

Locations
Other Locations
Italy
Istituto Europeo di Oncologia
RECRUITING
Milan
Contact Information
Primary
Carmen Criscitiello
carmen.criscitiello@ieo.it
00390294372689
Backup
Beatrice Taurelli Salimbeni
beatrice.taurellisalimbeni@ieo.it
00390294372035
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2025-11
Participants
Target number of participants: 60
Treatments
NEOADJUVANT SETTING
Neoadjuvant standard treatment for HER2+: A→Tax +T/P
ADJUVANT SETTING
Adjuvant standard treatment for HER2+ (N0): Tax + T (+/-ET); Adjuvant standard treatment for HER2+ (N+): A→Tax +T/P (+/- ET)
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov