This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with Aromatase inhibitors (AI), and a retrospective one with patients receiving adjuvant therapy with AI alone. Thus, both primary data collection and secondary use of data will be organized.
Signed and dated Informed Consent Form (ICF) not later than 28 days after the initiation of adjuvant therapy with ribociclib in combination with aromatase inhibitors (±GnRH agonists).
Age ≥18 years at the time of signing the ICF.
Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.
The adjuvant hormone therapy with aromatase inhibitors (±GnRH agonists) may be started not earlier than 12 months before initiation of therapy with ribociclib.
History of therapy with abemaciclib or palbociclib
Therapy with ribociclib in combination with AI for more than 28 days at the time of signing the Informed Consent Form
Active therapy for other malignant neoplasms
Participation in interventional clinical studies at the time of signing the Informed Consent Form