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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
RECRUITING
Milan
Azienda Ospedaliero-Universitaria di Modena
NOT_YET_RECRUITING
Modena
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
RECRUITING
Naples
ICS Maugeri IRCCS
RECRUITING
Pavia
Policlinico San Matteo
RECRUITING
Pavia
Azienda USL IRCCS di Reggio Emilia
RECRUITING
Reggio Emilia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NOT_YET_RECRUITING
Roma
Ospedale Isola Tiberina - Gemelli Isola
RECRUITING
Roma
Contact Information
Primary
Nadia Bianco, MD
nadia.bianco@ieo.it
+39 02 94371977
Time Frame
Start Date: 2025-09-29
Estimated Completion Date: 2030-08-01
Participants
Target number of participants: 750
Treatments
Group 1
Patients undergoing treatment with CDK4/6 inhibitors
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov