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
NCT04943497 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2424
Last updated 2026-04-01
Summary
This study is planned as a prospective multicenter NIS. This study is observational in nature and does 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 will be included into the study across seven Russian districts.
Conditions
Interventions
- OTHER
-
ribociclib
There is no treatment allocation. Patients administered ribociclib by prescription that have started before inclusion of the patient into the study will be enrolled.
- OTHER
-
aplelicib
There is no treatment allocation. Patients administered aplelicib by prescription that have started before inclusion of the patient into the study will be enrolled.
- OTHER
-
mono endocrine therapy
There is no treatment allocation. Patients administered mono endocrine therapy by prescription that have started before inclusion of the patient into the study will be enrolled.
- OTHER
-
chemotherapy
There is no treatment allocation. Patients administered chemotherapy by prescription that have started before inclusion of the patient into the study will be enrolled.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-27
- Primary Completion
- 2025-07-28
- Completion
- 2025-07-28
Countries
- Russia
Study Locations
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