Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: Evaluation in the Real-world Setting
Status: Recruiting
Location: See all (18) locations...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Female (regardless of menopausal status) or male ≥18 years of age;
• The patient has confirmed HR+, HER2-, early-stage resected invasive breast cancer candidate to adjuvant CDK4/6 inhibitors (abemaciclib or ribociclib);
• ER and PgR positivity is defined as evidence of immunohistochemical staining ≥ 1% according to ASCO/CAP recommendations; HER2 negativity is defined as expression of the membrane protein in immunohistochemistry 0 or 1+ or with a 2+ in situ hybridization (ISH) test negative as per ASCO/CAP recommendations;
• Patients who are initiating or have initiated adjuvant treatment with a CDK4/6 inhibitor (abemaciclib or ribociclib) in combination with endocrine therapy (ET). Treatment must have started on or after January 1, 2021.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
• Consent to data treatment according to the local regulation.
Locations
Other Locations
Italy
ASST Papa Giovanni XXIII
NOT_YET_RECRUITING
Bergamo
ASST Spedali Civili di Brescia
RECRUITING
Brescia
P.O. Antonio Perrino - ASL Brindisi
NOT_YET_RECRUITING
Brindisi
ASST Ospedale Maggiore di Crema
RECRUITING
Crema
ASST Lecco - PO Alessandro Manzoni
NOT_YET_RECRUITING
Lecco
Asst Ovest Milanese
NOT_YET_RECRUITING
Legnano
European Institute of Oncology
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
NOT_YET_RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
PO Luigi Sacco - ASST Fatebenefratelli Sacco
NOT_YET_RECRUITING
Milan
Azienda Ospedaliero-Universitaria di Modena
NOT_YET_RECRUITING
Modena
Fondazione IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale