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

NCT06625333 | Active Not Recruiting

• 1 other identifier: CLEE011ARU06
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

HR+HER2- Advanced Breast Cancer

Keywords

HR+HER2- advanced breast cancer, ribociclib, elderly patients

Outcome Measures

Primary Outcomes (1)

• change of QoL (RAND SF-36)

  The primary endpoint of the study is the change of QoL during treatment with ribociclib+ET from baseline to the level at 12 months (RAND SF-36) across all age's subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) and depend on treatment lines (first-line (1L) or in second-line (2L) settings)

  from baseline to the level at 12 months

Secondary Outcomes (10)

• Time to treatment failure (TTF)

  up to two years

• Progression free survival rate (PFS)

  up to two years

• Median progression free survival

  up tp two years

• Overall survival rate (OS)

  up to two years

• Objective response rate (ORR)

  up to two years

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

elderly patients with HR+HER2- advanced breast cancer

You may qualify if:

• Age ≥ 65 years at the moment of ribociclib+ET initiation
• Female/Male gender
• 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
• Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study
• Provision of written informed consent.

You may not qualify if:

• Patients with a life expectancy of less than 3 months per the investigator's judgment
• 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)
• Patients on active treatment for malignancies other than aBC within 3 years before BC diagnosis
• Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF \> 450 msec).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Novartis Investigative Site

Arkhangelsk, 163045, Russia

Location

Novartis Investigative Site

Barnaul, 656045, Russia

Location

Novartis Investigative Site

Bryansk, 241028, Russia

Location

Novartis Investigative Site

Chelyabinsk, 454080, Russia

Location

Novartis Investigative Site

Irkutsk, 664035, Russia

Location

Novartis Investigative Site

Kemerovo, 650036, Russia

Location

Novartis Investigative Site

Khabarovsk, 680042, Russia

Location

Novartis Investigative Site

Khanty-Mansiysk, 628012, Russia

Location

Novartis Investigative Site

Kirov, 610021, Russia

Location

Novartis Investigative Site

Krasnoyarsk, 660022, Russia

Location

Novartis Investigative Site

Obninsk, 249036, Russia

Location

Novartis Investigative Site

Perm, 614066, Russia

Location

Novartis Investigative Site

Rostov-on-Don, 344006, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194291, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197758, Russia

Location

Novartis Investigative Site

Tambov, 392000, Russia

Location

Novartis Investigative Site

Tver', 170008, Russia

Location

Novartis Investigative Site

Ufa, 450054, Russia

Location

Novartis Investigative Site

Yaroslavl, 150054, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620036, Russia

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 3, 2024
• Study Start: October 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (20)