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

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: ribociclib; Other: mono endocrine therapy; Other: aplelicib; Other: chemotherapy

• Registration Number: NCT04943497
• Lead Sponsor: Novartis Pharmaceuticals

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-29
• Study Start: 2021-07-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3290

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ribociclib + AI/fulvestrant	ribociclib	Patients administered ribociclib + AI/fulvestrant by prescription AI: Aromatase inhibitor
mono endocrine therapy	mono endocrine therapy	Patients administered mono endocrine therapy by prescription
aplelicib + fulvestrant	aplelicib	Patients administered aplelicib + fulvestrant by prescription
chemotherapy	chemotherapy	Patients administered chemotherapy by prescription

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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.
Location of metastases	Baseline	Locations of metastatic sited at study entry: * Local; * Lung; * Liver; * Central nervous system (CNS); * Bone; * Other
Number of patients with comorbidities	Baseline	Number of patients with comorbidities will be presented
Proportions of patients by treatment pattern	Up to 24 months	Proportions of patients receiving the pre-stablished treatments
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).
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 (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.
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.
Menopausal status	Baseline	Menopausal status; * Premenopausal; * Ovarian suppression; * Ovarian ablation; * Perimenopausal; * Ovarian suppression; * Ovarian ablation; * Postmenopausal
PIK3CA mutation status	Baseline	PIK3CA mutation status; * Confirmed PIK3CA mutation; * Confirmed absence of PIK3CA mutation; * No data available
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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇷🇺 Voronezh, Russian Federation