NCT06930859 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
| NCT ID | NCT06930859 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,766 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2032-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,766 participants in total. It began in 2025-12-03 with a primary completion date of 2032-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: Patients from the prospective cohort of the study must meet all of the following criteria: 1. 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). 2. Age ≥18 years at the time of signing the ICF. 3. Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out. 4. The adjuvant hormone therapy with aromatase inhibitors (±GnRH agonists) may be started not earlier than 12 months before initiation of therapy with ribociclib. 5. ECOG performance status 0-1 Patients from the retrospective cohort of the study must meet all of the following criteria: 1. Age ≥18 years at the initiation of hormone therapy. 2. Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out. 3. Initiation of adjuvant hormone monotherapy with aromatase inhibitors (±GnRH agonists) in the index period from July 1, 2019 to July 1, 2020. 4. 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. 1. History of therapy with abemaciclib or palbociclib 2. Therapy with ribociclib in combination with AI for more than 28 days at the time of signing the Informed Consent Form 3. Active therapy for other malignant neoplasms 4. 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. 1. Neoadjuvant or adjuvant therapy with CDK4/6 inhibitors 2. A history of another concomitant malignant neoplasm requiring active therapy 3. Participation in interventional clinical studies at the time of treatment for breast cancer 4. Patients experiencing a recurrence during adjuvant hormone therapy can participate if they meet the other inclusion and exclusion criteria.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06930859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06930859 currently recruiting?
Yes, NCT06930859 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06930859 trial being conducted?
This trial is being conducted at Kaluga, Russia, Pskov, Russia, Ryazan, Russia, Saint Petersburg, Russia and 11 additional locations.
Who is sponsoring the NCT06930859 clinical trial?
NCT06930859 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 2,766 participants.
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