Evaluating ribociclib with endocrine therapy in elderly patients with advanced 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 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.

Why it matters

Who can join: the full rules

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 it's running

• Novartis Investigative Site
  Arkhangelsk, Russian Federation Recruiting
• Novartis Investigative Site
  Barnaul, Russian Federation Recruiting
• Novartis Investigative Site
  Bryansk, Russian Federation Recruiting
• Novartis Investigative Site
  Chelyabinsk, Russian Federation Recruiting
• Novartis Investigative Site
  Ekaterinburg, Russian Federation Recruiting
• Novartis Investigative Site
  Irkutsk, Russian Federation 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.