Breast Cancer Clinical Trials

Find Breast Cancer Clinical Trials Near You

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
RECRUITING
Naples
ICS Maugeri IRCCS
RECRUITING
Pavia
Policlinico San Matteo
NOT_YET_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