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Evaluating ribociclib with endocrine therapy in elderly patients with advanced breast cancer in Russia

A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation

Observational Novartis · NCT06625333

This study is testing if a combination of ribociclib and hormone therapy can help older patients with advanced breast cancer in Russia feel better and improve their quality of life.

Quick facts

Study typeObservational
Enrollment328 (estimated)
Ages65 Years to 99 Years
SexAll
SponsorNovartis Industry-sponsored
Locations17 sites (Arkhangelsk and 16 other locations)
Trial IDNCT06625333 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness, safety, and quality of life of older patients (aged 65 and above) with HR+HER2- advanced breast cancer who are receiving ribociclib in combination with endocrine therapy in real-world clinical settings in Russia. It involves a prospective, non-interventional design where patients will be followed for 24 months after starting treatment. The study will collect primary data through routine clinical visits, which are expected to occur every 3-4 months, and interim analyses will be conducted after enrollment and one year later.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 65 years and older who have been diagnosed with HR+HER2- advanced breast cancer and are starting treatment with ribociclib and endocrine therapy.

Not a fit: Patients with a life expectancy of less than 3 months or those currently participating in 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 ribociclib combined with endocrine therapy for elderly patients with advanced breast cancer.

How similar studies have performed: While this study focuses on a specific demographic and treatment combination, similar approaches in evaluating ribociclib have shown promise in other populations, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 65 years at the moment of ribociclib+ET initiation
2. Female/Male gender
3. Confirmed diagnosis of locally advanced/metastatic not eligible for curative surgery HR+HER2- BC for whom the treating physician took the decision to initiate treatment with ribociclib+IA/FUL in the first or in the second line of the treatment
4. Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study
5. Provision of written informed consent.

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 within 3 years before BC diagnosis
4. Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF \> 450 msec).

Where this trial is running

Arkhangelsk and 16 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 → Find more trials like this →
Conditions HR+HER2- Advanced Breast CancerHR+HER2- advanced breast cancer, ribociclib, elderly patients
Last reviewed 2026-06-13 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.