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Observational study of treatment outcomes in advanced breast cancer patients in Russia

A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg® (Ribociclib), Piqray® (Alpelisib), Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia

Novartis · NCT04943497

This study looks at how well different treatments work for women in Russia with advanced breast cancer who are starting new medications.

Quick facts

Study typeObservational
Enrollment3290 (estimated)
Ages18 Years to 99 Years
SexFemale
SponsorNovartis (industry)
Drugs / interventionschemotherapy
Locations40 sites (Syktyvkar, Komi Republic and 39 other locations)
Trial IDNCT04943497 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect data on clinical outcomes, treatment patterns, and patient characteristics among women with HR+/HER2- advanced breast cancer who are starting treatment with ribociclib, alpelisib, endocrine therapy, or chemotherapy. Patients will be followed in routine clinical practice across multiple sites in Russia, with visits occurring every 3-4 months. The study will gather information from standard procedures and tests as determined by the treating physician, without imposing a specific treatment protocol. The total duration of the study is planned for four years, with a recruitment period of 24 months.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older with confirmed HR+/HER2- advanced or metastatic breast cancer who have recently initiated treatment with ribociclib, alpelisib, endocrine therapy, or chemotherapy.

Not a fit: Patients with a life expectancy of less than three 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 and safety of various treatment options for advanced breast cancer patients.

How similar studies have performed: Other studies have shown success in observing treatment patterns and outcomes in similar patient populations, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 18 years at the moment of ribociclib, alpelisib, monoET or CT treatment initiation.
2. Female gender.
3. Confirmed diagnosis of locally advanced/metastatic not amenable to surgery HR+/HER2- BC (progressed following prior therapy or de novo) for whom the treating physicial took the decision to initiate treatment with ribociclib, alpelisib, monoET or CT before entering the study.
4. Patient who initiated treatment with ribociclib, alpelisib, monoET or CT no longer than 4 weeks (28 days) prior to written informed consent for this study.
5. Patients with ECOG performance status ≤ 2.
6. Provision of written informed consent.

Exclusion Criteria:

1. Patients with a life expectancy of less than 3 months at the time of aBC diagnosis 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 trial or NIS can be included as long as their standard of care is not altered by the study).
3. Patients receiving active treatment for malignancies other than BC at the time of enrollment.
4. Patients who are unable to understand the nature of the study.

Where this trial is running

Syktyvkar, Komi Republic and 39 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, CDK4/6 inhibitors, advanced HR+/HER2- breast cancer, ribociclib, Risarg, alpelisib, Piqray, Russia

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.