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

Last updated: December 2, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

mono endocrine therapy

aplelicib

ribociclib

Clinical Study ID

NCT04943497
CLEE011ARU01
  • Ages 18-99
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years at the moment of ribociclib, alpelisib, monoET or CT treatmentinitiation.

  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 physicialtook the decision to initiate treatment with ribociclib, alpelisib, monoET or CTbefore entering the study.

  4. Patient who initiated treatment with ribociclib, alpelisib, monoET or CT no longerthan 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

Exclusion Criteria:

  1. Patients with a life expectancy of less than 3 months at the time of aBC diagnosisper the investigator's judgment.

  2. Patients participating in any interventional clinical trial that includesinvestigational or marketed products at the time of enrollment. (Patientsparticipating in other investigator initiated trial or NIS can be included as longas their standard of care is not altered by the study).

  3. Patients receiving active treatment for malignancies other than BC at the time ofenrollment.

  4. Patients who are unable to understand the nature of the study.

Study Design

Total Participants: 2424
Treatment Group(s): 4
Primary Treatment: mono endocrine therapy
Phase:
Study Start date:
July 27, 2021
Estimated Completion Date:
July 28, 2025

Study Description

Patients will attend the sites in accordance with routine clinical practice. It is assumed that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement. Available data from routine clinical management of the patients will be collected at patients' visits to the clinical site. Patients enrolled in the study will be followed up until death or study close whichever occurs first. The recruitment period is planned for 24 months, observation period for maximum of 24 months, with total duration of study 4 years. Patients may discontinue from this NIS at any time.

Connect with a study center

  • Novartis Investigative Site

    Syktyvkar 485239, Komi 545854 167904
    Russia

    Site Not Available

  • Novartis Investigative Site

    Kaluga 553915, Russia 248007
    Russia

    Site Not Available

  • Novartis Investigative Site

    Sochi 491422, Russian Federation 354057
    Russia

    Site Not Available

  • Novartis Investigative Site

    Surgut 1490624, Tymen Area 628402
    Russia

    Site Not Available

  • Novartis Investigative Site

    Arkhangelsk 581049, 163045
    Russia

    Site Not Available

  • Novartis Investigative Site

    Barnaul 1510853, 656045
    Russia

    Site Not Available

  • Novartis Investigative Site

    Belgorod 578072, 308010
    Russia

    Site Not Available

  • Novartis Investigative Site

    Bryansk 571476, 241028
    Russia

    Site Not Available

  • Novartis Investigative Site

    Cheboksary 569696, 428020
    Russia

    Site Not Available

  • Novartis Investigative Site

    Chelyabinsk 1508291, 454087
    Russia

    Site Not Available

  • Novartis Investigative Site

    Cherkessk 569154, 369000
    Russia

    Site Not Available

  • Novartis Investigative Site

    Chita 2025339, 672027
    Russia

    Site Not Available

  • Novartis Investigative Site

    Irkutsk 2023469, 664035
    Russia

    Site Not Available

  • Novartis Investigative Site

    Ivanovo 555312, 153040
    Russia

    Site Not Available

  • Novartis Investigative Site

    Izhevsk 554840, 426009
    Russia

    Site Not Available

  • Novartis Investigative Site

    Kaliningrad 554234, 236016
    Russia

    Site Not Available

  • Novartis Investigative Site

    Khabarovsk 2022890, 680042
    Russia

    Site Not Available

  • Novartis Investigative Site

    Khanty-Mansiysk 1503772, 628012
    Russia

    Site Not Available

  • Novartis Investigative Site

    Kirov 548408, 610021
    Russia

    Site Not Available

  • Novartis Investigative Site

    Kostroma 543878, 156005
    Russia

    Site Not Available

  • Novartis Investigative Site

    Krasnodar 542420, 350040
    Russia

    Site Not Available

  • Novartis Investigative Site

    Krasnoyarsk 1502026, 660022
    Russia

    Site Not Available

  • Novartis Investigative Site

    Moscow 524901, 143423
    Russia

    Site Not Available

  • Novartis Investigative Site

    Moscow Region Balas, 143900
    Russia

    Site Not Available

  • Novartis Investigative Site

    Nal'chik 523523, 360051
    Russia

    Site Not Available

  • Novartis Investigative Site

    Nizhny Novgorod 520555, 603081
    Russia

    Site Not Available

  • Novartis Investigative Site

    Novosibirsk 1496747, 630108
    Russia

    Site Not Available

  • Novartis Investigative Site

    Odintsovo 516215, 143003
    Russia

    Site Not Available

  • Novartis Investigative Site

    Omsk 1496153, 644013
    Russia

    Site Not Available

  • Novartis Investigative Site

    Perm 511196, 614066
    Russia

    Site Not Available

  • Novartis Investigative Site

    Podolsk 508101, 142110
    Russia

    Site Not Available

  • Novartis Investigative Site

    Pyatigorsk 503550, 357502
    Russia

    Site Not Available

  • Novartis Investigative Site

    Rostov-on-Don 501175, 344006
    Russia

    Site Not Available

  • Novartis Investigative Site

    Saint Petersburg 498817, 194214
    Russia

    Site Not Available

  • Novartis Investigative Site

    Saransk 498698, 430032
    Russia

    Site Not Available

  • Novartis Investigative Site

    Saratov 498677, 410053
    Russia

    Site Not Available

  • Novartis Investigative Site

    Sestroretsk 496478, 197706
    Russia

    Site Not Available

  • Novartis Investigative Site

    Sevastopol’ 496443, 299045
    Russia

    Site Not Available

  • Novartis Investigative Site

    Severodvinsk 496285, 450054
    Russia

    Site Not Available

  • Novartis Investigative Site

    Simferopol, 295023
    Russia

    Site Not Available

  • Novartis Investigative Site

    Tambov 484646, 392000
    Russia

    Site Not Available

  • Novartis Investigative Site

    Tula 480562, 300040
    Russia

    Site Not Available

  • Novartis Investigative Site

    Tver' 480060, 170008
    Russia

    Site Not Available

  • Novartis Investigative Site

    Tyumen 1488754, 625041
    Russia

    Site Not Available

  • Novartis Investigative Site

    Ufa 479561, 450054
    Russia

    Site Not Available

  • Novartis Investigative Site

    Vladikavkaz 473249, 362002
    Russia

    Site Not Available

  • Novartis Investigative Site

    Vladivostok 2013348, 690105
    Russia

    Site Not Available

  • Novartis Investigative Site

    Voronezh 472045, 394036
    Russia

    Site Not Available

  • Novartis Investigative Site

    Yekaterinburg 1486209, 620036
    Russia

    Site Not Available

  • Novartis Investigative Site

    Yuzhno-Sakhalinsk 2119441, 693010
    Russia

    Site Not Available

  • Novartis Investigative Site

    Syktyvkar, Komi Republic 167904
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Surgut, Tymen Area 628402
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Arkhangelsk, 163045
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Barnaul, 656045
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Belgorod, 308010
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Bryansk, 241028
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Cheboksary, 428020
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Chelyabinsk, 454087
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Ekaterinburg, 620027
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Irkutsk, 664035
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Ivanovo, 153040
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Kaluga, 248007
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Khabarovsk, 680042
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Khanty-Mansiysk, 628012
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Kostroma, 156005
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Krasnoyarsk, 660022
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Moscow, 111123
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Nalchik, 360051
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Nizhniy Novgorod, 603081
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Novosibirsk, 630108
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Perm, 614066
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Podolsk, 142110
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Pyatigorsk, 357502
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Rostov-On-Don, 344006
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Saint Petersburg, 191104
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Saransk, 430032
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Saratov, 410053
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Sevastopol, 299045
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Simferopol, 295023
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    St Petersburg, 197758
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Tambov, 392000
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Tula, 300040
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Tver, 170008
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Tyumen, 625000
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Ufa, 450054
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Vladivostok, 690105
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Voronezh, 394036
    Russian Federation

    Site Not Available

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