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Ribociclib with hormone therapy after surgery for HR+ HER2‑negative stage II–III breast cancer in Russia

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

Novartis · NCT06930859

This project will try ribociclib together with an aromatase inhibitor in adults in Russia who had surgery for HR+ HER2‑negative stage II–III breast cancer to see how well it works and how safe it is.

Quick facts

Study typeObservational
Enrollment2766 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorNovartis (industry)
Locations37 sites (Kaluga, Russia and 36 other locations)
Trial IDNCT06930859 on ClinicalTrials.gov

What this trial studies

This is a prospective–retrospective, multicenter observational program in Russia comparing a prospective cohort receiving adjuvant ribociclib plus an aromatase inhibitor (± GnRH agonist) with a retrospective cohort treated with aromatase inhibitor alone. Patients will be grouped by tumor grade, lymph node involvement, and response to a short test of hormone therapy to explore which subgroups derive the most benefit. The project collects primary prospective data on the ribociclib cohort and uses secondary source data for the historical comparator. Outcomes include real-world measures of effectiveness and safety during routine clinical practice.

Who should consider this trial

Good fit: Adults (≥18) in Russia with histologically confirmed HR+ HER2‑negative stage II–III breast cancer who completed radical treatment and are starting or have started adjuvant aromatase inhibitor therapy, with prospective participants requiring ECOG 0–1 and initiation of AI within the prior 12 months before ribociclib.

Not a fit: Patients with HER2‑positive or metastatic (stage IV) disease, those unable to tolerate ribociclib, or those who began aromatase inhibitor therapy more than 12 months before starting ribociclib are unlikely to benefit from the ribociclib treatment arm in this program.

Why it matters

Potential benefit: If successful, adding ribociclib to adjuvant hormone therapy could lower recurrence risk and improve disease‑free outcomes for patients with HR+ HER2‑negative stage II–III breast cancer.

How similar studies have performed: Ribociclib has proven benefit in combination with endocrine therapy for metastatic HR+ breast cancer, and its use in the adjuvant setting is being actively tested in large randomized trials.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Kaluga, Russia and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Breast Cancer, Breast cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.