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NCT04943497

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

2390

Start Date

2021-07-27

Completion Date

2025-07-28

Last Updated

2026-08-13

Healthy Volunteers

No

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.

Locations (58)

Novartis Investigative Site

Syktyvkar, Komi, Russia

Novartis Investigative Site

Sochi, Russian Federation, Russia

Novartis Investigative Site

Kaluga, Russia, Russia

Novartis Investigative Site

Surgut, Tymen Area, Russia

Novartis Investigative Site

Arkhangelsk, Russia

Novartis Investigative Site

Barnaul, Russia

Novartis Investigative Site

Belgorod, Russia

Novartis Investigative Site

Bryansk, Russia

Novartis Investigative Site

Cheboksary, Russia

Novartis Investigative Site

Chelyabinsk, Russia

Novartis Investigative Site

Cherkessk, Russia

Novartis Investigative Site

Chita, Russia

Novartis Investigative Site

Irkutsk, Russia

Novartis Investigative Site

Ivanovo, Russia

Novartis Investigative Site

Izhevsk, Russia

Novartis Investigative Site

Kaliningrad, Russia

Novartis Investigative Site

Khabarovsk, Russia

Novartis Investigative Site

Khanty-Mansiysk, Russia

Novartis Investigative Site

Kirov, Russia

Novartis Investigative Site

Kostroma, 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

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow Region Balas, Russia

Novartis Investigative Site

Nal'chik, Russia

Novartis Investigative Site

Nizhny Novgorod, Russia

Novartis Investigative Site

Novosibirsk, Russia

Novartis Investigative Site

Odintsovo, Russia

Novartis Investigative Site

Omsk, Russia

Novartis Investigative Site

Perm, Russia

Novartis Investigative Site

Podolsk, Russia

Novartis Investigative Site

Pyatigorsk, Russia

Novartis Investigative Site

Rostov-on-Don, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Saransk, Russia

Novartis Investigative Site

Saratov, Russia

Novartis Investigative Site

Sestroretsk, Russia

Novartis Investigative Site

Sevastopol’, Russia

Novartis Investigative Site

Severodvinsk, Russia

Novartis Investigative Site

Simferopol, Russia

Novartis Investigative Site

Tambov, Russia

Novartis Investigative Site

Tula, Russia

Novartis Investigative Site

Tver', Russia

Novartis Investigative Site

Tyumen, Russia

Novartis Investigative Site

Ufa, Russia

Novartis Investigative Site

Vladikavkaz, Russia

Novartis Investigative Site

Vladivostok, Russia

Novartis Investigative Site

Voronezh, Russia

Novartis Investigative Site

Yekaterinburg, Russia

Novartis Investigative Site

Yekaterinburg, Russia

Novartis Investigative Site

Yuzhno-Sakhalinsk, Russia