Status:
RECRUITING
EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to describe the percentage of patients with HER2-positive and Triple Negative tumour underwent neoadjuvant treatment in clinical practice during the past 5 years...
Eligibility Criteria
Inclusion
- For primary endpoint assessment we calculated the percentage of HER2 positive and Triple Negative patients who underwent neoadjuvant treatment in the past 5 years in each site. For this aim all patients with early breast cancer diagnosis who underwent neoadjuvant treatment during the study time, ranging from 01/01/2016 to 01/01/2021, will be included if they had:
- Histological diagnosis of infiltrating breast cancer performed by breast and/or axillary nodes biopsy;
- Age ≥ 18 years at the time of disease onset;
- Absence of secondary lesions, i.e. initial disease stage I, II or III;
- Known status of ER, PgR, HER-2 and Ki67.
Exclusion
- Documented distant disease at onset diagnosis or within 3 months from breast surgery;
- Prior neoadjuvant hormonal treatment exposure;
- Prior diagnosis of primary breast cancer or second primitive tumour starting from different organ
Key Trial Info
Start Date :
December 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 3 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06894173
Start Date
December 3 2022
End Date
December 3 2026
Last Update
March 25 2025
Active Locations (29)
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1
IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano
Aviano, PN, Italy, 33081
2
AOU Ospedali Riuniti Torrette di Ancona
Ancona, Italy, 60126
3
A.O.R.N. "San Giuseppe Moscati"
Avellino, Italy, 83100
4
Presidio di Brindisi Di Summa - Perrino
Brindisi, Italy, 72100