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

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Combination chemotherapy

Ribociclib

Clinical Study ID

NCT06148506
CLEE011ARU04
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years at the moment of ribociclib+ET or CT initiation.

  2. Female/Male gender.

  3. Luminal A, Luminal B subtype.

  4. Patients with ECOG performance status ≤ 2.

  5. Confirmed diagnosis of locally advanced/metastatic not eligible to surgery HR+HER2-BC (de novo) for whom the treating physician took the decision to initiate treatmentwith ribociclib+IA/FUL or combination chemotherapy before entering the study in thefirst line of the treatment.

  6. Multiple visceral metastases (including stable CNS mts).

  7. Pre-/Pere /postmenopause.

  8. Patient who initiated treatment with ribociclib+IA/FUL or combination chemotherapyno longer than 4 weeks (28 days) prior to written informed consent for this study.

Exclusion

Exclusion Criteria:

  1. Patients with a life expectancy of less than 3 months per the investigator'sjudgment.

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

  3. Patients on active treatment for malignancies other than aBC at the time ofenrollment.

  4. Patients who are unable to understand the nature of the study and are unwilling tosign an informed consent.

  5. Patients with visceral crisis (according to ABC5 definition*) *Visceral crisis isdefined as severe organ dysfunction, as assessed by signs and symptoms, laboratorystudies and rapid progression of disease. Visceral crisis is not the mere presenceof visceral metastases but implies important organ compromise leading to a clinicalindication for the most rapidly efficacious therapy [8].

Examples: Liver visceral crisis: rapidly increasing bilirubin >1.5 ULN in the absence of Gilbert's syndrome or biliary tract obstruction. Lung visceral crisis: rapidly increasing dyspnoea at rest, not alleviated by drainage of pleural effusion

Study Design

Total Participants: 376
Treatment Group(s): 2
Primary Treatment: Combination chemotherapy
Phase:
Study Start date:
December 28, 2023
Estimated Completion Date:
June 30, 2027

Study Description

Patients with HR+HER2- advanced breast cancer that initiated treatment with ribociclib+ET or combination CT will be enrolled. Approximately, 188 patients will be included into each treatment cohort of the study across different study sites in the Russian Federation and will be assigned to one of the below treatment arms:

  • Ribociclib arm: ribociclib (600 mg, 3 weeks on/1 week off)+ IA/FUL + goserilin for premenopausal patients (N = 188)

  • Combination chemotherapy arm: physician's choice (N = 188) The study will consist of pre-index period, index date and follow up period. Retrospective data will be collected as such: Medical history, previous treatment for Breast cancer (neoad'uvant and ad'uvant if applicable).In this study an index date is defined as a start of ribociclib+ET or chemotherapy treatment. Post-index follow-up period is 24 months or Progressive disease.

Patients will attend the sites in accordance with routine clinical practice. It is assumed according to the clinical practice that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement. No additional diagnostic or monitoring procedures will be applied to the patients and epidemiological methods shall be used for the analysis of collected data. 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.

Connect with a study center

  • Novartis Investigative Site

    Barnaul, 656045
    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

    Izhevsk, 426009
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Kaluga, 248007
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Kemerovo, 650036
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Krasnodar, 350040
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Krasnoyarsk, 660022
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Moscow, 115304
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Moscow Region Istra Village, 143423
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Nalchik, 360051
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Podolsk, 142110
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Saransk, 430032
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Tambov, 392000
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Tver, 170008
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Ufa, 450054
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Vladikavkaz, 362002
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Yaroslavl, 150054
    Russian Federation

    Active - Recruiting

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