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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: 2390

Last updated 2026-08-13

No results posted yet for this study

Summary

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

Interventions

OTHER

ribociclib

There was no treatment allocation. Patients administered ribociclib by prescription that had started before inclusion of the patient into the study were enrolled.

OTHER

aplelicib

There was no treatment allocation. Patients administered aplelicib by prescription that had started before inclusion of the patient into the study were enrolled.

OTHER

mono endocrine therapy

There was no treatment allocation. Patients administered mono endocrine therapy by prescription that had started before inclusion of the patient into the study were enrolled.

OTHER

chemotherapy

There was no treatment allocation. Patients administered chemotherapy by prescription that had started before inclusion of the patient into the study were enrolled.

Sponsors & Collaborators

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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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04943497 on ClinicalTrials.gov