Clinical trial NCT06625333: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HR+HER2- Advanced Breast Cancer
Keywords: HR+HER2- advanced breast cancer, ribociclib, elderly patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-10-03
Enrollment: 328
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly patients with HR+HER2- advanced breast cancer

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: change of QoL (RAND SF-36)
timeFrame: from baseline to the level at 12 months
Secondary outcomes:
measure: Time to treatment failure (TTF)
timeFrame: up to two years
measure: Progression free survival rate (PFS)
timeFrame: up to two years
measure: Median progression free survival
timeFrame: up tp two years
measure: Overall survival rate (OS)
timeFrame: up to two years
measure: Objective response rate (ORR)
timeFrame: up to two years
measure: Clinical benefit rate (CBR)
timeFrame: up to two years
measure: Proportions (%) of patients and reasons of permanent discontinuation of ribociclib
timeFrame: up to two years
measure: Proportions (%) of patients and reasons of dose adjustment on ribocicli
timeFrame: up to two years
measure: Adverse events (AEs) frequency and severity
timeFrame: up to two years
measure: Quality of life (RAND SF-36, questionnaire of patient's satisfaction)
timeFrame: up to two years
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Novartis Investigative Site
city: Barnaul
country: Russian Federation
facility: Novartis Investigative Site
city: Bryansk
country: Russian Federation
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Irkutsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Khabarovsk
country: Russian Federation
facility: Novartis Investigative Site
city: Khanty Mansiysk
country: Russian Federation
facility: Novartis Investigative Site
city: Kirov
country: Russian Federation
facility: Novartis Investigative Site
city: Krasnoyarsk
country: Russian Federation
facility: Novartis Investigative Site
city: Obninsk
country: Russian Federation
facility: Novartis Investigative Site
city: Perm
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov On Don
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tambov
country: Russian Federation
facility: Novartis Investigative Site
city: Tver
country: Russian Federation
facility: Novartis Investigative Site
city: Ufa
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
References: