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: January 11, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

chemotherapy

mono endocrine therapy

aplelicib

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: 3290
Treatment Group(s): 4
Primary Treatment: chemotherapy
Phase:
Study Start date:
July 27, 2021
Estimated Completion Date:
June 30, 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, Komi Republic 167904
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Surgut, Tymen Area 628402
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Arkhangelsk, 163045
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Barnaul, 656045
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Belgorod, 308010
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Bryansk, 241028
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Cheboksary, 428020
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Chelyabinsk, 454087
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Ekaterinburg, 620036
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Irkutsk, 664035
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Ivanovo, 153040
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Kaluga, 248007
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Khabarovsk, 680042
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Khanty-Mansiysk, 628012
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Kostroma, 156005
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Krasnoyarsk, 660022
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Moscow, 111123
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Nalchik, 360051
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Nizhniy Novgorod, 603081
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Novosibirsk, 630108
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Perm, 614066
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Podolsk, 142110
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Pyatigorsk, 357502
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Rostov-On-Don, 344006
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Saint Petersburg, 191104
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Saransk, 430032
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Saratov, 410053
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Sevastopol, 299045
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Simferopol, 295023
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    St Petersburg, 197758
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Tambov, 392000
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Tula, 300040
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Tver, 170008
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Tyumen, 625000
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Ufa, 450054
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Vladivostok, 690105
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Voronezh, 394036
    Russian Federation

    Active - Recruiting

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