Actively Recruiting
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
Led by European Institute of Oncology · Updated on 2026-05-07
750
Participants Needed
18
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female (regardless of menopausal status) or male 18 years of age or older
- Confirmed HR+, HER2-, early-stage resected invasive breast cancer eligible for adjuvant CDK4/6 inhibitors (abemaciclib or ribociclib)
- Estrogen receptor (ER) and progesterone receptor (PgR) positive defined as immunohistochemical staining of 1% or more as per ASCO/CAP guidelines
- HER2 negative defined as immunohistochemistry 0 or 1+ or negative in situ hybridization (ISH) test as per ASCO/CAP guidelines
- Starting or have started adjuvant CDK4/6 inhibitor treatment with endocrine therapy on or after January 1, 2021
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Provide consent for data treatment according to local regulations
You will not qualify if you...
- Currently participating in any other HR+/HER2- early breast cancer study involving investigational products
- Previously received adjuvant CDK4/6 inhibitor treatment as part of a clinical trial
- Unable to comply with study requirements or judged unsuitable by the study physician
- History of previous breast cancer except ductal carcinoma in situ (DCIS) treated with locoregional therapy more than 5 years ago
- History of other cancers except non-melanoma skin cancer or carcinoma in situ of the cervix unless in complete remission without therapy for at least 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
ASST Papa Giovanni XXIII
Bergamo, Italy, Italy, 24127
Not Yet Recruiting
2
ASST Spedali Civili di Brescia
Brescia, Italy, Italy, 25123
Actively Recruiting
3
P.O. Antonio Perrino - ASL Brindisi
Brindisi, Italy, Italy, 72100
Not Yet Recruiting
4
ASST Ospedale Maggiore di Crema
Crema, Italy, Italy, 26013
Actively Recruiting
5
ASST Lecco - PO Alessandro Manzoni
Lecco, Italy, Italy, 23900
Not Yet Recruiting
6
Asst Ovest Milanese
Legnano, Italy, Italy, 20025
Not Yet Recruiting
7
IRCCS Ospedale San Raffaele
Milan, Italy, Italy, 20132
Actively Recruiting
8
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Italy, Italy, 20133
Not Yet Recruiting
9
European Institute of Oncology
Milan, Italy, Italy, 20141
Actively Recruiting
10
PO Luigi Sacco - ASST Fatebenefratelli Sacco
Milan, Italy, Italy, 20157
Actively Recruiting
11
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy, Italy, 41125
Not Yet Recruiting
12
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, Italy, 20900
Not Yet Recruiting
13
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy, Italy, 80131
Actively Recruiting
14
ICS Maugeri IRCCS
Pavia, Italy, Italy, 27100
Actively Recruiting
15
Policlinico San Matteo
Pavia, Italy, Italy, 27100
Not Yet Recruiting
16
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy, Italy, 42122
Actively Recruiting
17
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, Italy, 00168
Not Yet Recruiting
18
Ospedale Isola Tiberina - Gemelli Isola
Roma, Italy, Italy, 00186
Actively Recruiting
Research Team
N
Nadia Bianco, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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