Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
Recruiting · NCT07180693 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
18 locations listed.
- ASST Papa Giovanni XXIII - Bergamo, Italy, Italy
- ASST Spedali Civili di Brescia - Brescia, Italy, Italy
- P.O. Antonio Perrino - ASL Brindisi - Brindisi, Italy, Italy
- ASST Ospedale Maggiore di Crema - Crema, Italy, Italy
- ASST Lecco - PO Alessandro Manzoni - Lecco, Italy, Italy
- Asst Ovest Milanese - Legnano, Italy, Italy
- IRCCS Ospedale San Raffaele - Milan, Italy, Italy
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Milan, Italy, Italy
- European Institute of Oncology - Milan, Italy, Italy
- PO Luigi Sacco - ASST Fatebenefratelli Sacco - Milan, Italy, Italy
- Azienda Ospedaliero-Universitaria di Modena - Modena, Italy, Italy
- Fondazione IRCCS San Gerardo dei Tintori - Monza, Italy, Italy
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Naples, Italy, Italy
- ICS Maugeri IRCCS - Pavia, Italy, Italy
- Policlinico San Matteo - Pavia, Italy, Italy
- Azienda USL IRCCS di Reggio Emilia - Reggio Emilia, Italy, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma, Italy, Italy
- Ospedale Isola Tiberina - Gemelli Isola - Roma, Italy, Italy