--- title: 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 nct_id: NCT04943497 overall_status: COMPLETED sponsor: Novartis Pharmaceuticals study_type: OBSERVATIONAL primary_condition: Breast Cancer countries: Russia canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04943497.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04943497" ct_last_update_post_date: 2026-04-01 last_seen_at: "2026-05-12T06:54:03.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **Official Title:** 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 **NCT ID:** [NCT04943497](https://clinicaltrials.gov/study/NCT04943497) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 2424 - **Lead Sponsor:** Novartis Pharmaceuticals - **Conditions:** Breast Cancer - **Start Date:** 2021-07-27 - **Completion Date:** 2025-07-28 - **CT.gov Last Update:** 2026-04-01 ## 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. ## Detailed Description 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 99 Years - **Sex:** FEMALE - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **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 ## 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. - **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. - **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. - **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. ## Primary Outcomes - **Time to treatment failure (TTF)** _(time frame: Up to 24 months)_ — 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. ## Secondary Outcomes - **Line of treatment** _(time frame: Baseline)_ - **ECOG status** _(time frame: Up to 24 months)_ - **Location of metastases** _(time frame: Baseline)_ - **Menopausal status** _(time frame: Baseline)_ - **Number of patients with comorbidities** _(time frame: Baseline)_ - **PIK3CA mutation status** _(time frame: Baseline)_ - **Proportions of patients by treatment pattern** _(time frame: Up to 24 months)_ - **Proportions (%) of patients by treatment sequence** _(time frame: Up to 24 months)_ - **Progression free survival (PFS)** _(time frame: Up to 24 months)_ - **Overall survival (OS)** _(time frame: Up to 24 months)_ - **Time to chemotherapy (TTC)** _(time frame: Up to 24 months)_ - **Proportion (%) of patients with permanent discontinuation** _(time frame: Up to 24 months)_ - **Reasons of permanent discontinuation** _(time frame: Up to 24 months)_ - **Proportion (%) of patients with dose adjustment** _(time frame: Up to 24 months)_ - **Reasons of dose adjustment** _(time frame: Up to 24 months)_ - **Quality of life (EORTC QLQ-C30)** _(time frame: Baseline)_ - **Quality of life (EQ-5D-5L)** _(time frame: Baseline)_ ## Locations (58) - Novartis Investigative Site, Syktyvkar, Komi, Russia - Novartis Investigative Site, Sochi, Russian Federation, Russia - Novartis Investigative Site, Kaluga, Russia, Russia - Novartis Investigative Site, Surgut, Tymen Area, Russia - Novartis Investigative Site, Arkhangelsk, Russia - Novartis Investigative Site, Barnaul, Russia - Novartis Investigative Site, Belgorod, Russia - Novartis Investigative Site, Bryansk, Russia - Novartis Investigative Site, Cheboksary, Russia - Novartis Investigative Site, Chelyabinsk, Russia - Novartis Investigative Site, Cherkessk, Russia - Novartis Investigative Site, Chita, Russia - Novartis Investigative Site, Irkutsk, Russia - Novartis Investigative Site, Ivanovo, Russia - Novartis Investigative Site, Izhevsk, Russia - Novartis Investigative Site, Kaliningrad, Russia - Novartis Investigative Site, Khabarovsk, Russia - Novartis Investigative Site, Khanty-Mansiysk, Russia - Novartis Investigative Site, Kirov, Russia - Novartis Investigative Site, Kostroma, Russia - Novartis Investigative Site, Krasnodar, Russia - Novartis Investigative Site, Krasnoyarsk, Russia - Novartis Investigative Site, Moscow, Russia - Novartis Investigative Site, Moscow, Russia - Novartis Investigative Site, Moscow, Russia - Novartis Investigative Site, Moscow, Russia - Novartis Investigative Site, Moscow, Russia - Novartis Investigative Site, Moscow, Russia - Novartis Investigative Site, Moscow Region Balas, Russia - Novartis Investigative Site, Nal'chik, Russia - Novartis Investigative Site, Nizhny Novgorod, Russia - Novartis Investigative Site, Novosibirsk, Russia - Novartis Investigative Site, Odintsovo, Russia - Novartis Investigative Site, Omsk, Russia - Novartis Investigative Site, Perm, Russia - Novartis Investigative Site, Podolsk, Russia - Novartis Investigative Site, Pyatigorsk, Russia - Novartis Investigative Site, Rostov-on-Don, Russia - Novartis Investigative Site, Saint Petersburg, Russia - Novartis Investigative Site, Saint Petersburg, Russia - Novartis Investigative Site, Saint Petersburg, Russia - Novartis Investigative Site, Saransk, Russia - Novartis Investigative Site, Saratov, Russia - Novartis Investigative Site, Sestroretsk, Russia - Novartis Investigative Site, Sevastopol’, Russia - Novartis Investigative Site, Severodvinsk, Russia - Novartis Investigative Site, Simferopol, Russia - Novartis Investigative Site, Tambov, Russia - Novartis Investigative Site, Tula, Russia - Novartis Investigative Site, Tver', Russia - Novartis Investigative Site, Tyumen, Russia - Novartis Investigative Site, Ufa, Russia - Novartis Investigative Site, Vladikavkaz, Russia - Novartis Investigative Site, Vladivostok, Russia - Novartis Investigative Site, Voronezh, Russia - Novartis Investigative Site, Yekaterinburg, Russia - Novartis Investigative Site, Yekaterinburg, Russia - Novartis Investigative Site, Yuzhno-Sakhalinsk, Russia ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.novartis investigative site|bryansk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|cheboksary||russia` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.novartis investigative site|syktyvkar|komi|russia` — added _(2026-05-12)_ - `locations.novartis investigative site|sochi|russian federation|russia` — added _(2026-05-12)_ - `locations.novartis investigative site|kaluga|russia|russia` — added _(2026-05-12)_ - `locations.novartis investigative site|surgut|tymen area|russia` — added _(2026-05-12)_ - `locations.novartis investigative site|arkhangelsk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|barnaul||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|belgorod||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|chelyabinsk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|cherkessk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|chita||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|irkutsk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|ivanovo||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|izhevsk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|kaliningrad||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|khabarovsk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|khanty-mansiysk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|kirov||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|kostroma||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|krasnodar||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|krasnoyarsk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|moscow||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|moscow region balas||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|nal'chik||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|nizhny novgorod||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|novosibirsk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|odintsovo||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|omsk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|perm||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|podolsk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|pyatigorsk||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|rostov-on-don||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|saint petersburg||russia` — added _(2026-05-12)_ - `locations.novartis investigative site|saransk||russia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04943497.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04943497* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*