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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

NCT ID: NCT06625333

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

328 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-11

Study Completion Date

2027-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HR+HER2- Advanced Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 surgery HR+HER2- BC for whom the treating physician took the decision to initiate treatment with 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 (28 days) prior to written informed consent for this study
5. Provision of written informed consent.

Exclusion Criteria

1. Patients with a life expectancy of less than 3 months per the investigator's judgment
2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study)
3. Patients on active treatment for malignancies other than aBC within 3 years before BC diagnosis
4. Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF \> 450 msec).
Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Arkhangelsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Barnaul, , Russia

Site Status RECRUITING

Novartis Investigative Site

Bryansk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Chelyabinsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Irkutsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Kemerovo, , Russia

Site Status RECRUITING

Novartis Investigative Site

Khabarovsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Khanty-Mansiysk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Kirov, , Russia

Site Status RECRUITING

Novartis Investigative Site

Krasnoyarsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Obninsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Perm, , Russia

Site Status RECRUITING

Novartis Investigative Site

Rostov-on-Don, , Russia

Site Status RECRUITING

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status RECRUITING

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status RECRUITING

Novartis Investigative Site

Tambov, , Russia

Site Status RECRUITING

Novartis Investigative Site

Tver', , Russia

Site Status RECRUITING

Novartis Investigative Site

Ufa, , Russia

Site Status RECRUITING

Novartis Investigative Site

Yaroslavl, , Russia

Site Status RECRUITING

Novartis Investigative Site

Yekaterinburg, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

[email protected]
+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CLEE011ARU06

Identifier Type: -

Identifier Source: org_study_id

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