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Evaluating the outcomes of ribociclib with endocrine therapy or chemotherapy in advanced breast cancer patients in Russia

A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in the Russian Federation

Novartis · NCT06148506

This study is testing whether adding ribociclib to standard hormone therapy or chemotherapy helps people in Russia with advanced breast cancer feel better and live longer.

Quick facts

Study typeObservational
Enrollment376 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorNovartis (industry)
Drugs / interventionschemotherapy
Locations21 sites (Barnaul and 20 other locations)
Trial IDNCT06148506 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the clinical outcomes of ribociclib combined with endocrine therapy or chemotherapy in patients with HR+HER2- advanced breast cancer in a real-world setting in Russia. Approximately 376 patients will be enrolled, with 188 receiving ribociclib and endocrine therapy and 188 receiving a physician's choice of chemotherapy. The study will collect primary data on patient outcomes over a follow-up period of 24 months, starting from the initiation of treatment. No additional interventions or diagnostic procedures will be imposed beyond standard clinical practice.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with HR+HER2- advanced breast cancer who have recently initiated treatment with ribociclib and endocrine therapy or chemotherapy.

Not a fit: Patients with a life expectancy of less than 3 months or those participating in other interventional clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of ribociclib in combination with standard therapies for advanced breast cancer, potentially improving treatment strategies.

How similar studies have performed: Other studies have shown promising results with ribociclib in similar patient populations, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 18 years at the moment of ribociclib+ET or CT initiation.
2. Female/Male gender.
3. Luminal A, Luminal B subtype.
4. Patients with ECOG performance status ≤ 2.
5. Confirmed diagnosis of locally advanced/metastatic not eligible to surgery HR+HER2- BC (de novo) for whom the treating physician took the decision to initiate treatment with ribociclib+IA/FUL or combination chemotherapy before entering the study in the first line of the treatment.
6. Multiple visceral metastases (including stable CNS mts).
7. Pre-/Pere /postmenopause.
8. Patient who initiated treatment with ribociclib+IA/FUL or combination chemotherapy no longer than 4 weeks (28 days) prior to written informed consent for this study.

Exclusion Criteria:

1. Patients with a life expectancy of less than 3 months per the investigator's judgment.
2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study).
3. Patients on active treatment for malignancies other than aBC at the time of enrollment.
4. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.
5. Patients with visceral crisis (according to ABC5 definition\*) \*Visceral crisis is defined as severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease. Visceral crisis is not the mere presence of visceral metastases but implies important organ compromise leading to a clinical indication for the most rapidly efficacious therapy \[8\].

Examples: Liver visceral crisis: rapidly increasing bilirubin \>1.5 ULN in the absence of Gilbert's syndrome or biliary tract obstruction. Lung visceral crisis: rapidly increasing dyspnoea at rest, not alleviated by drainage of pleural effusion

Where this trial is running

Barnaul and 20 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: HR+HER2- Advanced Breast Cancer, HR+HER2- advanced breast cancer,, ribociclib+ET,, Chemotherapy, ribociclib, NIS

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.