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ACTIVE NOT RECRUITING
NCT06148506

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

376

Start Date

2023-12-28

Completion Date

2027-06-30

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

OTHER

Ribociclib

There is no treatment allocation. Participants with HR+HER2- aBC that initiated treatment with ribociclib+ET by prescription within the study enrollment timeline will be recruited.

OTHER

Combination chemotherapy

There is no treatment allocation. Participants with HR+HER2- aBC that initiated treatment with CT by prescription within the study enrollment timeline will be recruited.

Locations (20)

Novartis Investigative Site

Kaluga, Russia, Russia

Novartis Investigative Site

Barnaul, Russia

Novartis Investigative Site

Chelyabinsk, Russia

Novartis Investigative Site

Irkutsk, Russia

Novartis Investigative Site

Izhevsk, Russia

Novartis Investigative Site

Kemerovo, Russia

Novartis Investigative Site

Krasnodar, Russia

Novartis Investigative Site

Krasnoyarsk, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Nal'chik, Russia

Novartis Investigative Site

Podolsk, Russia

Novartis Investigative Site

Saransk, Russia

Novartis Investigative Site

Tambov, Russia

Novartis Investigative Site

Tver', Russia

Novartis Investigative Site

Ufa, Russia

Novartis Investigative Site

Vladikavkaz, Russia

Novartis Investigative Site

Yaroslavl, Russia

Novartis Investigative Site

Yekaterinburg, Russia