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
Patients with HR+HER2- stage II-III breast cancer receiving adjuvant therapy with ribociclib combined with AI will be include in prospective cohort. Patients with HR+HER2- stage II-III breast cancer receiving adjuvant therapy with AI alone will be included in retrospective cohort.
Cohort
Prospective
Ribociclib
DrugCDK4/6 inhibitor
Letrozole
DrugAromatase inhibitor
Anastrozole
DrugAromatase inhibitor
Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort
IBCFS at M36, M48, and M60 according to the STEEP 2.0 criteria in a prospective cohort (defined as the time from the start of therapy to one of the listed events: ipsilateral invasive recurrence of breast cancer, locoregional invasive recurrence, distant recurrence, breast cancer-related death, death not associated with breast cancer progression, death from unknown cause, contralateral invasive recurrence of breast cancer) depending on the tumor grade (G2/G3) and the status of lymph node involvement (N0/N1/N2-3)
Invasive breast cancer-free survival in prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3).
IBCFS at M36, M48, and M60 according to the STEEP 2.0 criteria in prospective and retrospective cohorts (defined as the time from the start of therapy to one of the listed events: ipsilateral invasive recurrence of breast cancer, locoregional invasive recurrence, distant recurrence, breast cancer-related death, death not associated with breast cancer progression, death from unknown cause, contralateral invasive recurrence of breast cancer) depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3).
Invasive disease-free survival (IDFS) in prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3).
IDFS is defined as the time from surgery until first occurrence of invasive breast cancer recurrence, distant recurrence, or death from any cause
Recurrence-free survival (RFS) in the prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3).
Recurrence-free survival is the length of time after the treatment of the cancer ends that the patient survives without cancer symptoms.
Number of doses taken relative to the total planned doses of ribociclib %
To evaluate the dose intensity of ribociclib.
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