This is a multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+/HER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.
The study will also evaluate clinico-pathologic characteristics, patterns of recurrence, therapeutic choices and outcomes of the subgroup of patients relapsed during or within 12 months after adjuvant therapy with CDK4/6 inhibitors in combination with ET.
Study Type
OBSERVATIONAL
Enrollment
750
ASST Papa Giovanni XXIII
Bergamo, Italy, Italy
NOT_YET_RECRUITINGInvasive-disease free survival (IDFS)
Invasive disease-free survival (IDFS) will be defined as the time from surgery to invasive loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death from any cause, whichever occurs first.
Time frame: 3 years
Distant relapse-free survival (DRFS)
DRFS will be defined as the time from surgery to distant recurrence or death from any cause, whichever occurs first.
Time frame: 5 years
progression-free survival (PFS)
PFS will be defined as the time from the disease recurrence to the date of documented disease progression or death from any cause, whichever occurs first.
Time frame: 5 years
Overall survival (OS)
OS will be defined as the time from surgery to death from any cause.
Time frame: 5 years
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ASST Spedali Civili di Brescia
Brescia, Italy, Italy
P.O. Antonio Perrino - ASL Brindisi
Brindisi, Italy, Italy
NOT_YET_RECRUITINGASST Ospedale Maggiore di Crema
Crema, Italy, Italy
RECRUITINGASST Lecco - PO Alessandro Manzoni
Lecco, Italy, Italy
NOT_YET_RECRUITINGAsst Ovest Milanese
Legnano, Italy, Italy
NOT_YET_RECRUITINGIRCCS Ospedale San Raffaele
Milan, Italy, Italy
RECRUITINGFondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Italy, Italy
NOT_YET_RECRUITINGEuropean Institute of Oncology
Milan, Italy, Italy
RECRUITINGPO Luigi Sacco - ASST Fatebenefratelli Sacco
Milan, Italy, Italy
RECRUITING...and 8 more locations