Study Description
This study is planned as a prospective multicenter NIS. This study is observational in
nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a
visit schedule. Patients with HR+/ HER2- advanced or metastatic BC that initiated
treatment with ribociclib, alpelisib, mono endocrine therapy or chemotherapy will be
included into the study across seven Russian districts. Patients will attend the sites in accordance with routine clinical practice. It is
assumed that visits will be conducted every 3-4 months. Patients will undergo standard
procedures and tests according to clinical guidelines and physician's judgement.
Available data from routine clinical management of the patients will be collected at
patients' visits to the clinical site. Patients enrolled in the study will be followed up
until death or study close whichever occurs first. The recruitment period is planned for
24 months, observation period for maximum of 24 months, with total duration of study 4
years. Patients may discontinue from this NIS at any time.
Interventions
aplelicib
chemotherapy
mono endocrine therapy
ribociclib
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years at the moment of ribociclib, alpelisib, monoET or CT treatment
initiation.
2. Female gender.
3. Confirmed diagnosis of locally advanced/metastatic not amenable to surgery HR+/HER2-
BC (progressed following prior therapy or de novo) for whom the treating physicial
took the decision to initiate treatment with ribociclib, alpelisib, monoET or CT
before entering the study.
4. Patient who initiated treatment with ribociclib, alpelisib, monoET or CT no longer
than 4 weeks (28 days) prior to written informed consent for this study.
5. Patients with ECOG performance status ≤ 2.
6. Provision of written informed consent.
Exclusion Criteria:
1. Patients with a life expectancy of less than 3 months at the time of aBC diagnosis
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 trial or NIS can be included as long
as their standard of care is not altered by the study).
3. Patients receiving active treatment for malignancies other than BC at the time of
enrollment.
4. Patients who are unable to understand the nature of the study.
Worldwide Contacts
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