Clinical Trials in Italy / NCT07180693
Recruiting
Observational
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
NCT07180693 · tracked via the Priya Life Science Italy tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More European Institute of Oncology trials in Italy
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