The study will also evaluate clinico-pathologic characteristics, patterns of recurrence, therapeutic choices and outcomes of the subgroup of patients relapsed during or within 12 months after adjuvant therapy with CDK4/6 inhibitors in combination with ET.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
