NCT06625333Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
This is а prospective, non-interventional, primary data collection study to evaluate the effectiveness, safety and quality of life in older patients (≥65 years) with HR+HER2- advanced breast cancer receiving ribociclib with ET in the first or second line in the real-life settings in Russia.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 329 (actual)
- First submitted
- 2 Oct 2024
- Start date
- 11 Oct 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06625333
What you commit to
- Study type: Observational
- Participants enrolled: 329
- From 11 Oct 2024 to the primary completion date, 31 Dec 2027
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients on active treatment for malignancies other than aBC within 3 years before BC diagnosis
Lab values
- Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF \> 450 msec).
Other
- Patients with a life expectancy of less than 3 months per the investigator's judgment
- 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)
Who the study is looking for
- Age ≥ 65 years at the moment of ribociclib+ET initiation
- Female/Male gender
- 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
- Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study
- Provision of written informed consent.
Age in the registry: 65 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.