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

NCT04943497 | Completed DMC

• 1 other identifier: CLEE011ARU01
• Study Type: observational
• Target: 2,424
• Locations: 1 country
• Sites: 58

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; CDK4/6 inhibitors; advanced HR+/HER2- breast cancer; ribociclib; Risarg; alpelisib; Piqray; Russia

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure (TTF)

  Defined as the time from study treatment initiation to the earliest of date of progression, date of death due to any cause, or date of discontinuation due to reasons other than 'Protocol violation' or 'Administrative problems'. The time to treatment failure for patients who did not experience treatment failure will be censored at last adequate tumor assessment.

  Up to 24 months

Secondary Outcomes (17)

• Line of treatment

  Baseline

• ECOG status

  Up to 24 months

• Location of metastases

  Baseline

• Menopausal status

  Baseline

• Number of patients with comorbidities

  Baseline

Study Arms (4)

ribociclib + AI/fulvestrant

Patients administered ribociclib + AI/fulvestrant by prescription AI: Aromatase inhibitor

Other: ribociclib

aplelicib + fulvestrant

Patients administered aplelicib + fulvestrant by prescription

Other: aplelicib

mono endocrine therapy

Patients administered mono endocrine therapy by prescription

Other: mono endocrine therapy

chemotherapy

Patients administered chemotherapy by prescription

Other: chemotherapy

Interventions

ribociclib OTHER

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

ribociclib + AI/fulvestrant

aplelicib OTHER

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

aplelicib + fulvestrant

chemotherapy OTHER

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

chemotherapy

mono endocrine therapy OTHER

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.

mono endocrine therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Women with HR+/ HER2- advanced or metastatic BC that initiated treatment with ribociclib, alpelisib, monoET or CT within the study enrollment timeline
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with HR+/ HER2- advanced or metastatic BC that initiated treatment with ribociclib, alpelisib, monoET or CT within the study enrollment timeline will be provided by national oncology centers and hospitals that will be selected based on their experience in treating Breast Cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (58)

Novartis Investigative Site

Syktyvkar, Komi, 167904, Russia

Location

Novartis Investigative Site

Sochi, Russian Federation, 354057, Russia

Location

Novartis Investigative Site

Kaluga, Russia, 248007, Russia

Location

Novartis Investigative Site

Surgut, Tymen Area, 628402, Russia

Location

Novartis Investigative Site

Arkhangelsk, 163045, Russia

Location

Novartis Investigative Site

Barnaul, 656045, Russia

Location

Novartis Investigative Site

Belgorod, 308010, Russia

Location

Novartis Investigative Site

Bryansk, 241028, Russia

Location

Novartis Investigative Site

Cheboksary, 428020, Russia

Location

Novartis Investigative Site

Chelyabinsk, 454087, Russia

Location

Novartis Investigative Site

Cherkessk, 369000, Russia

Location

Novartis Investigative Site

Chita, 672027, Russia

Location

Novartis Investigative Site

Irkutsk, 664035, Russia

Location

Novartis Investigative Site

Ivanovo, 153040, Russia

Location

Novartis Investigative Site

Izhevsk, 426009, Russia

Location

Novartis Investigative Site

Kaliningrad, 236016, Russia

Location

Novartis Investigative Site

Khabarovsk, 680042, Russia

Location

Novartis Investigative Site

Khanty-Mansiysk, 628012, Russia

Location

Novartis Investigative Site

Kirov, 610021, Russia

Location

Novartis Investigative Site

Kostroma, 156005, Russia

Location

Novartis Investigative Site

Krasnodar, 350040, Russia

Location

Novartis Investigative Site

Krasnoyarsk, 660022, Russia

Location

Novartis Investigative Site

Moscow, 105005, Russia

Location

Novartis Investigative Site

Moscow, 111123, Russia

Location

Novartis Investigative Site

Moscow, 115304, Russia

Location

Novartis Investigative Site

Moscow, 115522, Russia

Location

Novartis Investigative Site

Moscow, 129110, Russia

Location

Novartis Investigative Site

Moscow, 143423, Russia

Location

Novartis Investigative Site

Moscow Region Balas, 143900, Russia

Location

Novartis Investigative Site

Nal'chik, 360051, Russia

Location

Novartis Investigative Site

Nizhny Novgorod, 603081, Russia

Location

Novartis Investigative Site

Novosibirsk, 630108, Russia

Location

Novartis Investigative Site

Odintsovo, 143003, Russia

Location

Novartis Investigative Site

Omsk, 644013, Russia

Location

Novartis Investigative Site

Perm, 614066, Russia

Location

Novartis Investigative Site

Podolsk, 142110, Russia

Location

Novartis Investigative Site

Pyatigorsk, 357502, Russia

Location

Novartis Investigative Site

Rostov-on-Don, 344006, Russia

Location

Novartis Investigative Site

Saint Petersburg, 191104, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194214, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197758, Russia

Location

Novartis Investigative Site

Saransk, 430032, Russia

Location

Novartis Investigative Site

Saratov, 410053, Russia

Location

Novartis Investigative Site

Sestroretsk, 197706, Russia

Location

Novartis Investigative Site

Sevastopol’, 299045, Russia

Location

Novartis Investigative Site

Severodvinsk, 450054, Russia

Location

Novartis Investigative Site

Simferopol, 295023, Russia

Location

Novartis Investigative Site

Tambov, 392000, Russia

Location

Novartis Investigative Site

Tula, 300040, Russia

Location

Novartis Investigative Site

Tver', 170008, Russia

Location

Novartis Investigative Site

Tyumen, 625041, Russia

Location

Novartis Investigative Site

Ufa, 450054, Russia

Location

Novartis Investigative Site

Vladikavkaz, 362002, Russia

Location

Novartis Investigative Site

Vladivostok, 690105, Russia

Location

Novartis Investigative Site

Voronezh, 394036, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620027, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620036, Russia

Location

Novartis Investigative Site

Yuzhno-Sakhalinsk, 693010, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: July 27, 2021
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (58)