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

Breast Cancer Clinical Trial

— PROSPERITY  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943497
• Other study ID #: CLEE011ARU01
• Status: Recruiting
• Start date: July 27, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3290
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Novartis Investigative Site	Arkhangelsk
Russian Federation	Novartis Investigative Site	Barnaul
Russian Federation	Novartis Investigative Site	Belgorod
Russian Federation	Novartis Investigative Site	Bryansk
Russian Federation	Novartis Investigative Site	Cheboksary
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Irkutsk
Russian Federation	Novartis Investigative Site	Ivanovo
Russian Federation	Novartis Investigative Site	Kaluga
Russian Federation	Novartis Investigative Site	Khabarovsk
Russian Federation	Novartis Investigative Site	Khanty-Mansiysk
Russian Federation	Novartis Investigative Site	Kostroma
Russian Federation	Novartis Investigative Site	Krasnoyarsk
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Nalchik
Russian Federation	Novartis Investigative Site	Nizhniy Novgorod
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Perm
Russian Federation	Novartis Investigative Site	Podolsk
Russian Federation	Novartis Investigative Site	Pyatigorsk
Russian Federation	Novartis Investigative Site	Rostov-On-Don
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saransk
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Sevastopol
Russian Federation	Novartis Investigative Site	Simferopol
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	Surgut	Tymen Area
Russian Federation	Novartis Investigative Site	Syktyvkar	Komi Republic
Russian Federation	Novartis Investigative Site	Tambov
Russian Federation	Novartis Investigative Site	Tula
Russian Federation	Novartis Investigative Site	Tver
Russian Federation	Novartis Investigative Site	Tyumen
Russian Federation	Novartis Investigative Site	Ufa
Russian Federation	Novartis Investigative Site	Vladivostok
Russian Federation	Novartis Investigative Site	Voronezh

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Line of treatment	Line of advanced breast cancer therapy when treatment of interest was prescribed; 1st; 2nd; 3rd; Later lines	Baseline
Secondary	ECOG status	Eastern Cooperative Oncology Group (ECOG) Performance status: describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead)	Up to 24 months
Secondary	Location of metastases	Locations of metastatic sited at study entry: Local; Lung; Liver; Central nervous system (CNS); Bone; Other	Baseline
Secondary	Menopausal status	Menopausal status; Premenopausal; Ovarian suppression; Ovarian ablation; Perimenopausal; Ovarian suppression; Ovarian ablation; Postmenopausal	Baseline
Secondary	Number of patients with comorbidities	Number of patients with comorbidities will be presented	Baseline
Secondary	PIK3CA mutation status	PIK3CA mutation status; Confirmed PIK3CA mutation; Confirmed absence of PIK3CA mutation; No data available	Baseline
Secondary	Proportions of patients by treatment pattern	Proportions of patients receiving the pre-stablished treatments	Up to 24 months
Secondary	Proportions (%) of patients by treatment sequence	Proportions (%) of patients by treatment sequence: ribociclib in 1st line --> alpelisib in 2nd line.; alpelisib in 1st line --> ribociclib or other CDK4/6 inhibitor in 2nd line	Up to 24 months
Secondary	Progression free survival (PFS)	Defined as the time from index date to the date of the first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of the last adequate tumor assessment by local BC management guidelines.	Up to 24 months
Secondary	Overall survival (OS)	Defined as the time from index date to date of death due to any cause. If a patient is not known to have died, then OS will be censored at the latest date the patient was known to be alive (on or before the cut-off date).	Up to 24 months
Secondary	Time to chemotherapy (TTC)	Defined as the time from index date to the date of initiation of chemotherapy in patient who did not receive chemotherapy for advanced breast cancer at the inclusion. The time to chemotherapy for patients who did not receive any chemotherapy will be censored at the end of follow-up period.	Up to 24 months
Secondary	Proportion (%) of patients with permanent discontinuation	Proportion of patients with permanent discontinuation to becollected	Up to 24 months
Secondary	Reasons of permanent discontinuation	Reason of treatment discontinuation (if initial treatment was discontinued); Cancer progression; Adverse event; Death; Patient decision; Other	Up to 24 months
Secondary	Proportion (%) of patients with dose adjustment	Proportion of patients with dose adjustment will be collected	Up to 24 months
Secondary	Reasons of dose adjustment	Reasons of dose adjustment will be collected	Up to 24 months
Secondary	Quality of life (EORTC QLQ-C30)	The changes from baseline to each visit where measured using QLQ-C30. EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Subject's responses to 28 questions about their physical functioning, disease symptoms, global health status and utilities are scored on a 4-point scale (1=Not at all to 4=Very much), a low score indicates a high / healthy level of functioning. And the responses to 2 questions about health-related QoL are scored on a 7-point scale (1=Very poor to 7=Excellent), a high score indicates a high / healthy level of functioning.; Using linear transformation, raw scores are standardized, so that scores range from 0 to 100.	Baseline
Secondary	Quality of life (EQ-5D-5L)	EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.	Baseline