PROSPERITY: 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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04943497

Collaborator

(none)

3,290

Enrollment

Locations

47.1

Anticipated Duration (Months)

82.3

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: ribociclib Other: aplelicib Other: mono endocrine therapy Other: chemotherapy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

3290 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 27, 2021

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
ribociclib + AI/fulvestrant Patients administered ribociclib + AI/fulvestrant by prescription AI: Aromatase inhibitor	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 + fulvestrant Patients administered aplelicib + fulvestrant by prescription	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.
mono endocrine therapy Patients administered mono endocrine therapy by prescription	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.
chemotherapy Patients administered chemotherapy by prescription	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.

Outcome Measures

Primary Outcome Measures

Time to treatment failure (TTF) [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 Outcome Measures

Line of treatment [Baseline]
Line of advanced breast cancer therapy when treatment of interest was prescribed 1st 2nd 3rd Later lines
ECOG status [Up to 24 months]
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)
Location of metastases [Baseline]
Locations of metastatic sited at study entry: Local Lung Liver Central nervous system (CNS) Bone Other
Menopausal status [Baseline]
Menopausal status Premenopausal Ovarian suppression Ovarian ablation Perimenopausal Ovarian suppression Ovarian ablation Postmenopausal
Number of patients with comorbidities [Baseline]
Number of patients with comorbidities will be presented
PIK3CA mutation status [Baseline]
PIK3CA mutation status Confirmed PIK3CA mutation Confirmed absence of PIK3CA mutation No data available
Proportions of patients by treatment pattern [Up to 24 months]
Proportions of patients receiving the pre-stablished treatments
Proportions (%) of patients by treatment sequence [Up to 24 months]
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
Progression free survival (PFS) [Up to 24 months]
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.
Overall survival (OS) [Up to 24 months]
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).
Time to chemotherapy (TTC) [Up to 24 months]
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.
Proportion (%) of patients with permanent discontinuation [Up to 24 months]
Proportion of patients with permanent discontinuation to becollected
Reasons of permanent discontinuation [Up to 24 months]
Reason of treatment discontinuation (if initial treatment was discontinued) Cancer progression Adverse event Death Patient decision Other
Proportion (%) of patients with dose adjustment [Up to 24 months]
Proportion of patients with dose adjustment will be collected
Reasons of dose adjustment [Up to 24 months]
Reasons of dose adjustment will be collected
Quality of life (EORTC QLQ-C30) [Baseline]
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.
Quality of life (EQ-5D-5L) [Baseline]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Syktyvkar	Komi Republic	Russian Federation	167904
2	Novartis Investigative Site	Surgut	Tymen Area	Russian Federation	628402
3	Novartis Investigative Site	Arkhangelsk		Russian Federation	163045
4	Novartis Investigative Site	Barnaul		Russian Federation	656045
5	Novartis Investigative Site	Belgorod		Russian Federation	308010
6	Novartis Investigative Site	Bryansk		Russian Federation	241028
7	Novartis Investigative Site	Cheboksary		Russian Federation	428020
8	Novartis Investigative Site	Chelyabinsk		Russian Federation	454087
9	Novartis Investigative Site	Ekaterinburg		Russian Federation	620027
10	Novartis Investigative Site	Ekaterinburg		Russian Federation	620036
11	Novartis Investigative Site	Irkutsk		Russian Federation	664035
12	Novartis Investigative Site	Ivanovo		Russian Federation	153040
13	Novartis Investigative Site	Kaluga		Russian Federation	248007
14	Novartis Investigative Site	Khabarovsk		Russian Federation	680042
15	Novartis Investigative Site	Khanty-Mansiysk		Russian Federation	628012
16	Novartis Investigative Site	Kostroma		Russian Federation	156005
17	Novartis Investigative Site	Krasnoyarsk		Russian Federation	660022
18	Novartis Investigative Site	Moscow		Russian Federation	111123
19	Novartis Investigative Site	Moscow		Russian Federation	115478
20	Novartis Investigative Site	Moscow		Russian Federation	143423
21	Novartis Investigative Site	Nalchik		Russian Federation	360051
22	Novartis Investigative Site	Nizhniy Novgorod		Russian Federation	603081
23	Novartis Investigative Site	Novosibirsk		Russian Federation	630108
24	Novartis Investigative Site	Perm		Russian Federation	614066
25	Novartis Investigative Site	Podolsk		Russian Federation	142110
26	Novartis Investigative Site	Pyatigorsk		Russian Federation	357502
27	Novartis Investigative Site	Rostov-On-Don		Russian Federation	344006
28	Novartis Investigative Site	Saint Petersburg		Russian Federation	191104
29	Novartis Investigative Site	Saransk		Russian Federation	430032
30	Novartis Investigative Site	Saratov		Russian Federation	410053
31	Novartis Investigative Site	Sevastopol		Russian Federation	299045
32	Novartis Investigative Site	Simferopol		Russian Federation	295023
33	Novartis Investigative Site	St Petersburg		Russian Federation	197758
34	Novartis Investigative Site	Tambov		Russian Federation	392000
35	Novartis Investigative Site	Tula		Russian Federation	300040
36	Novartis Investigative Site	Tver		Russian Federation	170008
37	Novartis Investigative Site	Tyumen		Russian Federation	625000
38	Novartis Investigative Site	Ufa		Russian Federation	450054
39	Novartis Investigative Site	Vladivostok		Russian Federation	690105
40	Novartis Investigative Site	Voronezh		Russian Federation	394036