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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Novartis Investigative Site
  Sochi, Russian Federation, Russia Recruiting
• Novartis Investigative Site
  Kaluga, Russia, Russia Recruiting
• Novartis Investigative Site
  Pskov, Russia, Russia Recruiting
• Novartis Investigative Site
  Ryazan, Russia, Russia Recruiting
• Novartis Investigative Site
  Saint Petersburg, Russia, Russia Recruiting
• Novartis Investigative Site
  Surgut, Tymen Area, Russia Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.