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

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Novartis Investigative Site
RECRUITING
Arkhangelsk
Novartis Investigative Site
RECRUITING
Barnaul
Novartis Investigative Site
RECRUITING
Belgorod
Novartis Investigative Site
RECRUITING
Bryansk
Novartis Investigative Site
RECRUITING
Cheboksary
Novartis Investigative Site
RECRUITING
Chelyabinsk
Novartis Investigative Site
RECRUITING
Irkutsk
Novartis Investigative Site
RECRUITING
Ivanovo
Novartis Investigative Site
RECRUITING
Kaluga
Novartis Investigative Site
RECRUITING
Khabarovsk
Novartis Investigative Site
RECRUITING
Khanty-mansiysk
Novartis Investigative Site
RECRUITING
Kostroma
Novartis Investigative Site
RECRUITING
Krasnoyarsk
Novartis Investigative Site
RECRUITING
Moscow
Novartis Investigative Site
RECRUITING
Moscow
Novartis Investigative Site
RECRUITING
Moscow
Novartis Investigative Site
RECRUITING
Nal'chik
Novartis Investigative Site
RECRUITING
Nizhny Novgorod
Novartis Investigative Site
RECRUITING
Novosibirsk
Novartis Investigative Site
RECRUITING
Perm
Novartis Investigative Site
RECRUITING
Podolsk
Novartis Investigative Site
RECRUITING
Pyatigorsk
Novartis Investigative Site
RECRUITING
Rostov-on-don
Novartis Investigative Site
RECRUITING
Saint Petersburg
Novartis Investigative Site
RECRUITING
Saint Petersburg
Novartis Investigative Site
RECRUITING
Saransk
Novartis Investigative Site
RECRUITING
Saratov
Novartis Investigative Site
RECRUITING
Sevastopol’
Novartis Investigative Site
RECRUITING
Simferopol
Novartis Investigative Site
RECRUITING
Surgut
Novartis Investigative Site
RECRUITING
Syktyvkar
Novartis Investigative Site
RECRUITING
Tambov
Novartis Investigative Site
RECRUITING
Tula
Novartis Investigative Site
RECRUITING
Tver'
Novartis Investigative Site
RECRUITING
Tyumen
Novartis Investigative Site
RECRUITING
Ufa
Novartis Investigative Site
RECRUITING
Vladivostok
Novartis Investigative Site
RECRUITING
Voronezh
Novartis Investigative Site
RECRUITING
Yekaterinburg
Novartis Investigative Site
RECRUITING
Yekaterinburg
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2021-07-27
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 3290
Treatments
ribociclib + AI/fulvestrant
Patients administered ribociclib + AI/fulvestrant by prescription AI: Aromatase inhibitor
aplelicib + fulvestrant
Patients administered aplelicib + fulvestrant by prescription
mono endocrine therapy
Patients administered mono endocrine therapy by prescription
chemotherapy
Patients administered chemotherapy by prescription
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov