A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation

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

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06625333
CLEE011ARU06
  • Ages 65-99
  • All Genders

Study Summary

This is а prospective, non-interventional, primary data collection study to evaluate the effectiveness, safety and quality of life in older patients (≥65 years) with HR+HER2- advanced breast cancer receiving ribociclib with ET in the first or second line in the real-life settings in Russia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 65 years at the moment of ribociclib+ET initiation

  2. Female/Male gender

  3. Confirmed diagnosis of locally advanced/metastatic not eligible for curative surgeryHR+HER2- BC for whom the treating physician took the decision to initiate treatmentwith ribociclib+IA/FUL in the first or in the second line of the treatment

  4. Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28days) prior to written informed consent for this study

  5. Provision of written informed consent.

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 within 3 years beforeBC diagnosis

  4. Patients with active cardiac disease, or history of cardiac dysfunction, includingprolonged QT interval corrected using Fridericia's formula (QTcF > 450 msec).

Study Design

Total Participants: 328
Study Start date:
October 11, 2024
Estimated Completion Date:
October 30, 2027

Study Description

In this study, an index event is a start of ribociclib+ET treatment. Post-index follow-up period is 24 months or until treatment discontinuation. The recruitment period is planned for 12 months. The interim analyses will be performed after enrollment is complete, and further one year later. Patients will visit 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.

Connect with a study center

  • Novartis Investigative Site

    Arkhangelsk, 163045
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Barnaul, 656045
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Bryansk, 241028
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Chelyabinsk, 454080
    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

    Kemerovo, 650036
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Khabarovsk, 680042
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Kirov, 610021
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Krasnoyarsk, 660022
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Obninsk, 249036
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Perm, 614066
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Rostov On Don, 344006
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    St Petersburg, 194291
    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

    Yaroslavl, 150054
    Russian Federation

    Active - Recruiting

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