Status:
RECRUITING
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
All Genders
18-99 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
2766 Patients enrolled
Trial Details
Trial ID
NCT06930859
Start Date
December 3 2025
End Date
December 31 2032
Last Update
December 15 2025
Active Locations (12)
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1
Novartis Investigative Site
Kaluga, Russia, Russia, 248007
2
Novartis Investigative Site
Surgut, Tymen Area, Russia, 628402
3
Novartis Investigative Site
Barnaul, Russia, 656045
4
Novartis Investigative Site
Irkutsk, Russia, 664035