Clinical trial · Observational
A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is а prospective, non-interventional, primary data collection cohort study to evaluate the clinical outcomes of the combination of ribociclib + ET and combination chemotherapy in the real-life setting in Russia. This study is observational in nature; it does not impose a therapy, diagnostic/therapeutic interventions or a visit schedule.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HR+HER2- Advanced Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination chemotherapy | Other | — | UNRESOLVED |
| Ribociclib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Ribociclib Arm
- description
- ribociclib (600 mg, 3 weeks on/1 week off)+ IA/FUL + goserilin for premenopausal patients
- interventionNames
- Other: Ribociclib
- label
- Combination chemotherapy
- description
- The choice of which chemotherapy combination used on study is decided by the physician
- interventionNames
- Other: Combination chemotherapy
Primary outcomes (1)
- measure
- time to treatment failure (TTF)
- timeFrame
- Up to 24 months
- description
- The primary efficacy endpoint of the study is time to treatment failure (TTF) in in RIB + ET (AI/FUL) and combination chemotherapy cohorts. Time to treatment failure (TTF) is defined as the time from initiation of treatment to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available