Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Not listed
Trial groups
750 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov