Clinical trial · Observational
A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice 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
- 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 study was planned as a prospective multicenter NIS. This study was observational in nature and did not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule. Patients with HR+/ HER2- advanced or metastatic BC that initiated treatment with ribociclib, alpelisib, mono endocrine therapy or chemotherapy were included in the study across seven Russian districts.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aplelicib | Other | — | UNRESOLVED |
| chemotherapy | Other | — | UNRESOLVED |
| mono endocrine therapy | Other | — | UNRESOLVED |
| ribociclib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- ribociclib + AI/fulvestrant
- description
- Patients administered ribociclib + AI/fulvestrant by prescription AI: Aromatase inhibitor
- interventionNames
- Other: ribociclib
- label
- aplelicib + fulvestrant
- description
- Patients administered aplelicib + fulvestrant by prescription
- interventionNames
- Other: aplelicib
- label
- mono endocrine therapy
- description
- Patients administered mono endocrine therapy by prescription
- interventionNames
- Other: mono endocrine therapy
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available