Phase
Condition
N/ATreatment
Combination chemotherapy
Ribociclib
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years at the moment of ribociclib+ET or CT initiation.
Female/Male gender.
Luminal A, Luminal B subtype.
Patients with ECOG performance status ≤ 2.
Confirmed diagnosis of locally advanced/metastatic not eligible to surgery HR+HER2-BC (de novo) for whom the treating physician took the decision to initiate treatmentwith ribociclib+IA/FUL or combination chemotherapy before entering the study in thefirst line of the treatment.
Multiple visceral metastases (including stable CNS mts).
Pre-/Pere /postmenopause.
Patient who initiated treatment with ribociclib+IA/FUL or combination chemotherapyno longer than 4 weeks (28 days) prior to written informed consent for this study.
Exclusion
Exclusion Criteria:
Patients with a life expectancy of less than 3 months per the investigator'sjudgment.
Patients participating in any interventional clinical trial that includesinvestigational or marketed products at the time of enrollment. (Patientsparticipating in other investigator initiated research or NIS can be included aslong as their standard of care is not altered by the study).
Patients on active treatment for malignancies other than aBC at the time ofenrollment.
Patients who are unable to understand the nature of the study and are unwilling tosign an informed consent.
Patients with visceral crisis (according to ABC5 definition*) *Visceral crisis isdefined as severe organ dysfunction, as assessed by signs and symptoms, laboratorystudies and rapid progression of disease. Visceral crisis is not the mere presenceof visceral metastases but implies important organ compromise leading to a clinicalindication for the most rapidly efficacious therapy [8].
Examples: Liver visceral crisis: rapidly increasing bilirubin >1.5 ULN in the absence of Gilbert's syndrome or biliary tract obstruction. Lung visceral crisis: rapidly increasing dyspnoea at rest, not alleviated by drainage of pleural effusion
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Barnaul, 656045
Russian FederationActive - Recruiting
Novartis Investigative Site
Chelyabinsk, 454087
Russian FederationActive - Recruiting
Novartis Investigative Site
Ekaterinburg, 620036
Russian FederationActive - Recruiting
Novartis Investigative Site
Irkutsk, 664035
Russian FederationActive - Recruiting
Novartis Investigative Site
Izhevsk, 426009
Russian FederationActive - Recruiting
Novartis Investigative Site
Kaluga, 248007
Russian FederationActive - Recruiting
Novartis Investigative Site
Kemerovo, 650036
Russian FederationActive - Recruiting
Novartis Investigative Site
Krasnodar, 350040
Russian FederationActive - Recruiting
Novartis Investigative Site
Krasnoyarsk, 660022
Russian FederationActive - Recruiting
Novartis Investigative Site
Moscow, 115304
Russian FederationActive - Recruiting
Novartis Investigative Site
Moscow Region Istra Village, 143423
Russian FederationActive - Recruiting
Novartis Investigative Site
Nalchik, 360051
Russian FederationActive - Recruiting
Novartis Investigative Site
Podolsk, 142110
Russian FederationActive - Recruiting
Novartis Investigative Site
Saransk, 430032
Russian FederationActive - Recruiting
Novartis Investigative Site
Tambov, 392000
Russian FederationActive - Recruiting
Novartis Investigative Site
Tver, 170008
Russian FederationActive - Recruiting
Novartis Investigative Site
Ufa, 450054
Russian FederationActive - Recruiting
Novartis Investigative Site
Vladikavkaz, 362002
Russian FederationActive - Recruiting
Novartis Investigative Site
Yaroslavl, 150054
Russian FederationActive - Recruiting
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