Actively Recruiting
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: Evaluation in the Real-world Setting
Led by European Institute of Oncology · Updated on 2026-05-29
750
Participants Needed
18
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with hormone receptor-positive, HER2-negative early breast cancer (HR+/HER2- EBC) who are at high risk of their cancer returning. This observational study includes both past and future phases to assess the clinical and pathological features, treatment choices, and outcomes of patients treated with CDK4/6 inhibitors ribociclib or abemaciclib combined with endocrine therapy in the adjuvant setting. The study also focuses on patients whose cancer returned during or within 12 months after finishing this adjuvant treatment. Participants are those who have started or are starting adjuvant treatment with ribociclib or abemaciclib along with endocrine therapy since January 1, 2021. This study does not involve assigning treatments but observes patients receiving these therapies in real-world settings. It gathers data on treatment patterns, recurrence, and clinical outcomes without altering patient care. During the study, researchers will collect and analyze data on patient health, tumor characteristics, and treatment responses. They will track invasive disease-free survival over 3 years as the main outcome, along with distant relapse-free survival, progression-free survival, and overall survival up to 5 years. Participants will provide consent for their data to be used, and their health status will be monitored through routine medical records and follow-ups. The study is expected to continue until August 2030.
CONDITIONS
Brief Title
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male aged 18 years or older
- Confirmed hormone receptor-positive, HER2-negative early-stage resected invasive breast cancer
- ER and PgR positivity defined as immunohistochemical staining ≥ 1%
- HER2 negativity defined by immunohistochemistry 0 or 1+ or negative ISH test
- Initiating or have initiated adjuvant treatment with ribociclib or abemaciclib combined with endocrine therapy starting on or after January 1, 2021
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Consent to data treatment according to local regulations
You will not qualify if you...
- Current participation in another HR+/HER2- early breast cancer study with investigational products
- Previous adjuvant treatment with a CDK4/6 inhibitor as part of a clinical trial
- Inability to comply with study requirements or judged unsuitable by the study physician
- History of previous breast cancer except for ductal carcinoma in situ treated by locoregional therapy alone at least 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants undergoing treatment with CDK4/6 inhibitors are observed to evaluate clinical characteristics, patterns of recurrence, and outcomes.
Visit frequency as per routine clinical care
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
Actively 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
Actively 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
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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