Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia

Inclusion criteria

Patients from the prospective cohort of the study must meet all of the following criteria:

• 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.
• ECOG performance status 0-1

Patients from the retrospective cohort of the study must meet all of the following criteria:

• Age ≥18 years at the initiation of hormone therapy.
• Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.
• Initiation of adjuvant hormone monotherapy with aromatase inhibitors (±GnRH agonists) in the index period from July 1, 2019 to July 1, 2020.
• Presence of the necessary information in the source documentation.

Exclusion criteria

Patients enrolled in the study in prospective cohort should not meet any of the following criteria.

• 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 enrolled in the study in retrospective cohort should not meet any of the following criteria.

• Neoadjuvant or adjuvant therapy with CDK4/6 inhibitors
• A history of another concomitant malignant neoplasm requiring active therapy
• Participation in interventional clinical studies at the time of treatment for breast cancer
• Patients experiencing a recurrence during adjuvant hormone therapy can participate if they meet the other inclusion and exclusion criteria.