Study Description
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.
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).
Novartis Investigative Site
Recruiting
Krasnoyarsk,660022,Russian Federation
Novartis Investigative Site
Recruiting
Chelyabinsk,454080,Russian Federation
Novartis Investigative Site
Recruiting
Yaroslavl,150054,Russian Federation
Novartis Investigative Site
Recruiting
Obninsk,249036,Russian Federation
Novartis Investigative Site
Recruiting
Ekaterinburg,620036,Russian Federation
Novartis Investigative Site
Recruiting
Perm,614066,Russian Federation
Novartis Investigative Site
Recruiting
Irkutsk,664035,Russian Federation
Novartis Investigative Site
Recruiting
Rostov On Don,344006,Russian Federation
Novartis Investigative Site
Recruiting
Kemerovo,650036,Russian Federation
Novartis Investigative Site
Recruiting
Arkhangelsk,163045,Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg,194291,Russian Federation
Novartis Investigative Site
Recruiting
Khabarovsk,680042,Russian Federation
Novartis Investigative Site
Recruiting
Barnaul,656045,Russian Federation
Novartis Investigative Site
Recruiting
Tver,170008,Russian Federation
Novartis Investigative Site
Recruiting
Kirov,610021,Russian Federation
Novartis Investigative Site
Recruiting
Bryansk,241028,Russian Federation
Novartis Investigative Site
Recruiting
Ufa,450054,Russian Federation
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