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Recruiting Observational

Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:

NCT07180693 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-09-29
Last updated
2026-05-29

Condition(s) studied

Adjuvant TherapyCDK4/6 Inhibitor

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Current participation in any other HR+/HER2- EBC study with any investigational products; * Patients who have already received adjuvant treatment with a CDK4/6 inhibitor as part of a clinical trial; * Patients unable to comply with the requirements of the study or who, in the judge of the study physician, should not be included in the study; * Patients with a history of previous BC, with the exception of Ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago; * Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the index date, will be excluded, as well.

Primary outcome measure(s)

  • Invasive-disease free survival (IDFS) — 3 years
    Invasive disease-free survival (IDFS) will be defined as the time from surgery to invasive loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death from any cause, whichever occurs first.

Trial sites (18)

FacilityCityRegionStatus
ASST Papa Giovanni XXIII Bergamo Italy Not Yet Recruiting
ASST Spedali Civili di Brescia Brescia Italy Recruiting
P.O. Antonio Perrino - ASL Brindisi Brindisi Italy Not Yet Recruiting
ASST Ospedale Maggiore di Crema Crema Italy Recruiting
ASST Lecco - PO Alessandro Manzoni Lecco Italy Not Yet Recruiting
Asst Ovest Milanese Legnano Italy Not Yet Recruiting
IRCCS Ospedale San Raffaele Milan Italy Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano Milan Italy Not Yet Recruiting
European Institute of Oncology Milan Italy Recruiting
PO Luigi Sacco - ASST Fatebenefratelli Sacco Milan Italy Recruiting
Azienda Ospedaliero-Universitaria di Modena Modena Italy Not Yet Recruiting
Fondazione IRCCS San Gerardo dei Tintori Monza Italy Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Naples Italy Recruiting
ICS Maugeri IRCCS Pavia Italy Recruiting
Policlinico San Matteo Pavia Italy Recruiting
Azienda USL IRCCS di Reggio Emilia Reggio Emilia Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy Not Yet Recruiting
Ospedale Isola Tiberina - Gemelli Isola Roma Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07180693 on ClinicalTrials.gov ↗ ← All trials in Italy