A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia

A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg® (Ribociclib), Piqray® (Alpelisib), Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia

ClinicalTrials.gov Identifier: NCT04943497

Novartis Reference Number: CLEE011ARU01

Last Update: Feb 09, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

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.

Condition 
Breast Cancer
Phase 
Not Given
Overall status 
Recruiting
Start date 
Jul 27, 2021
Completion date 
Jun 30, 2025
Gender 
Female
Age(s)
18 Years - 99 Years (Adult, Older Adult)

Interventions

Other
ribociclib
There is no treatment allocation. Patients administered ribociclib by prescription that have started before inclusion of the patient into the study will be enrolled.
Other
aplelicib
There is no treatment allocation. Patients administered aplelicib by prescription that have started before inclusion of the patient into the study will be enrolled.
Other
mono endocrine therapy
There is no treatment allocation. Patients administered mono endocrine therapy by prescription that have started before inclusion of the patient into the study will be enrolled.
Other
chemotherapy
There is no treatment allocation. Patients administered chemotherapy by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years at the moment of ribociclib, alpelisib, monoET or CT treatment initiation.
Female gender.
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.
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.
Patients with ECOG performance status ≤ 2.
Provision of written informed consent.

Exclusion Criteria:

Patients with a life expectancy of less than 3 months at the time of aBC diagnosis per the investigator's judgment.
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).
Patients receiving active treatment for malignancies other than BC at the time of enrollment.
Patients who are unable to understand the nature of the study.

Study Locations

Russian Federation
Novartis Investigative Site
Recruiting
Syktyvkar, 167904
Komi Republic
Russian Federation
Novartis Investigative Site
Recruiting
Surgut, 628402
Tymen Area
Russian Federation
Novartis Investigative Site
Recruiting
Arkhangelsk, 163045
-
Russian Federation
Novartis Investigative Site
Recruiting
Barnaul, 656045
-
Russian Federation
Novartis Investigative Site
Recruiting
Belgorod, 308010
-
Russian Federation
Novartis Investigative Site
Recruiting
Bryansk, 241028
-
Russian Federation
Novartis Investigative Site
Recruiting
Cheboksary, 428020
-
Russian Federation
Novartis Investigative Site
Recruiting
Chelyabinsk, 454087
-
Russian Federation
Novartis Investigative Site
Recruiting
Ekaterinburg, 620027
-
Russian Federation
Novartis Investigative Site
Recruiting
Ekaterinburg, 620036
-
Russian Federation
Novartis Investigative Site
Recruiting
Irkutsk, 664035
-
Russian Federation
Novartis Investigative Site
Recruiting
Ivanovo, 153040
-
Russian Federation
Novartis Investigative Site
Recruiting
Kaluga, 248007
-
Russian Federation
Novartis Investigative Site
Recruiting
Khabarovsk, 680042
-
Russian Federation
Novartis Investigative Site
Recruiting
Khanty-Mansiysk, 628012
-
Russian Federation
Novartis Investigative Site
Recruiting
Kostroma, 156005
-
Russian Federation
Novartis Investigative Site
Recruiting
Krasnoyarsk, 660022
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 111123
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 115478
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 143423
-
Russian Federation
Novartis Investigative Site
Recruiting
Nalchik, 360051
-
Russian Federation
Novartis Investigative Site
Recruiting
Nizhniy Novgorod, 603081
-
Russian Federation
Novartis Investigative Site
Recruiting
Novosibirsk, 630108
-
Russian Federation
Novartis Investigative Site
Recruiting
Perm, 614066
-
Russian Federation
Novartis Investigative Site
Recruiting
Podolsk, 142110
-
Russian Federation
Novartis Investigative Site
Recruiting
Pyatigorsk, 357502
-
Russian Federation
Novartis Investigative Site
Recruiting
Rostov-On-Don, 344006
-
Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg, 191104
-
Russian Federation
Novartis Investigative Site
Recruiting
Saransk, 430032
-
Russian Federation
Novartis Investigative Site
Recruiting
Saratov, 410053
-
Russian Federation
Novartis Investigative Site
Recruiting
Sevastopol, 299045
-
Russian Federation
Novartis Investigative Site
Recruiting
Simferopol, 295023
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 197758
-
Russian Federation
Novartis Investigative Site
Recruiting
Tambov, 392000
-
Russian Federation
Novartis Investigative Site
Recruiting
Tula, 300040
-
Russian Federation
Novartis Investigative Site
Recruiting
Tver, 170008
-
Russian Federation
Novartis Investigative Site
Recruiting
Tyumen, 625000
-
Russian Federation
Novartis Investigative Site
Recruiting
Ufa, 450054
-
Russian Federation
Novartis Investigative Site
Recruiting
Vladivostok, 690105
-
Russian Federation
Novartis Investigative Site
Recruiting
Voronezh, 394036
-
Russian Federation

Contacts

Name: 
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Phone: 

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