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

N/AActive Not RecruitingNCT06625333

Novartis Pharmaceuticals329 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

329

Conditions

HR+HER2- Advanced Breast Cancer

Eligibility

Sex: ALLMin age: 65 YearsMax age: 99 Years

Medical Language ↔ Plain English

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).

Locations (20)

Novartis Investigative Site

Arkhangelsk, Russia

Novartis Investigative Site

Barnaul, Russia

Novartis Investigative Site

Bryansk, Russia

Novartis Investigative Site

Chelyabinsk, Russia

Novartis Investigative Site

Irkutsk, Russia

Novartis Investigative Site

Kemerovo, Russia

Novartis Investigative Site

Khabarovsk, Russia

Novartis Investigative Site

Khanty-Mansiysk, Russia

Novartis Investigative Site

Kirov, Russia

Novartis Investigative Site

Krasnoyarsk, Russia

...and 10 more locations

Outcomes

Primary Outcomes

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)

Time frame: from baseline to the level at 12 months

Secondary Outcomes

Time to treatment failure (TTF)

Time to treatment failure (TTF) in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)

Time frame: up to two years

Progression free survival rate (PFS)

Progression free survival rate (PFS) at 24 months in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)

Time frame: up to two years

Median progression free survival

Median progression free survival (if reached) in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)

Time frame: up tp two years

Overall survival rate (OS)

Overall survival rate (OS) at 24 months in HR+/HER2- aBC women initiating treatment with ribociclib+ET in across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)

Time frame: up to two years

Objective response rate (ORR)

Objective response rate (ORR) as assessed by the investigator in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)

Time frame: up to two years

Clinical benefit rate (CBR)

Clinical benefit rate (CBR) as assessed by the investigator in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L).

Time frame: up to two years

Proportions (%) of patients and reasons of permanent discontinuation of ribociclib

Time frame: up to two years

Proportions (%) of patients and reasons of dose adjustment on ribocicli

Time frame: up to two years

Adverse events (AEs) frequency and severity

Time frame: up to two years

Quality of life (RAND SF-36, questionnaire of patient's satisfaction)

Quality of life (RAND SF-36, questionnaire of patient's satisfaction) during treatment with ribociclib + ET (AI/FUL) across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) and in first-line (1L) and in second-line (2L) settings

Time frame: up to two years