A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 3,250
- Locations
- 285
- Primary Endpoint
- Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence
Study Overview
Brief Summary
This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.
Detailed Description
This non-interventional study aims to provide information on real-world effectiveness, safety and tolerability, management of adverse events, QoL and patient compliance of patients with HR+/HER2- early breast cancer at high risk of recurrence treated with ribociclib in combination with an aromatase inhibitor (AI) ± luteinizing hormone-releasing hormone (LHRH) with curative intent according to the current effective local summary of product characteristics.
In order to put the results of patients treated with ribociclib into perspective, socio-economic data, data on QoL and patient compliance will also be collected from patients treated with abemaciclib + endocrine therapy (ET) ± LHRH as described in the current effective local summary of product characteristics.
To understand reasons for treatment decision, and to analyze the clinical adoption of ribociclib + AI ± LHRH after EU approval over time, baseline data will be collected from cohorts of ribociclib + AI ± LHRH, abemaciclib + ET ± LHRH, and additionally from patients treated with ET monotherapy ± LHRH and analyzed cross-sectionally.
The study is planned to be rolled out into a broad set of German and Austrian breast centers and gynecological practices to describe clinical routine in a representative subset of the local healthcare eco-system. It will gather insights into the potential benefits and risks associated with ribociclib + AI ± LHRH in the adjuvant treatment of HR+/HER2- eBC patients at high risk of recurrence. This knowledge will inform about clinical decision-making and contribute to improved patient outcomes in routine practice.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histological diagnosis of HR+/HER2- early breast cancer with curative intent
- •Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + AI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC/"Fachinformation" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting
- •Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either
- •ribociclib + AI ± LHRH, or
- •ET mono ± LHRH, or
- •abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study.
- •Baseline = for ribociclib + AI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: within 4 weeks after therapy start or within 4 weeks after last non-endocrine based therapy, whichever is last.
- •≥18 years of age
- •Written informed consent
Exclusion Criteria
- •- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.
Arms & Interventions
ribociclib
ribociclib + AI ± LHRH
Intervention: ribociclib + AI ± LHRH (Drug)
abemaciclib
abemaciclib + ET ± LHRH
Intervention: abemaciclib + ET ± LHRH (Drug)
ET mono
ET mono ± LHRH
Intervention: ET mono ± LHRH (Drug)
Outcomes
Primary Outcomes
Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence
Time Frame: 36 months
iDFS using STEEP (Standardized Definitions for Efficacy Endpoints in Adjuvant Breast Cancer Trials) criteria, as assessed by the investigator. iDFS is defined as the time from study start to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
Secondary Outcomes
- Number of participants per Baseline parameters(baseline)
- Reasons for treatment decision by treating physician(baseline)
- Invasive disease-free survival (iDFS) (ribociclib cohort)(12 and 24 months)
- Invasive breast cancer-free survival (iBCFS) (ribociclib cohort)(12, 24 and 36 months)
- Recurrence-free survival (RFS) (ribociclib cohort)(12, 24 and 36 months)
- Distant disease-free survival (DDFS) (ribociclib cohort)(12, 24 and 36 months)
- Incidence and severity of adverse events (ribociclib cohort)(up to 36 months)
- Dose modification rates (ribociclib cohort)(up to 36 months)
- Treatment interruption rates (ribociclib cohort)(up to 36 months)
- Discontinuation rates (ribociclib cohort)(up to 36 months)
- Time to discontinuation (TTD) (ribociclib cohort)(up to 36 months)
- Quality of life by EORTC QLQ-C30 (ribociclib and abemaciclib cohorts)(up to 39 months)
- Quality of life by EORTC QLQ-BR42 (ribociclib and abemaciclib cohorts)(up to 39 months)
- Quality of life by HADS D (ribociclib and abemaciclib cohorts)(up to 39 months)
- Participant compliance as assessed by a physician adherence rating (ribociclib cohort)(up to 36 months)
- Participant compliance as assessed by neutrophil count (ribociclib cohort)(up to 36 months)
- Socio-economic status of participants measured by WPAI-GH (ribociclib and abemaciclib cohorts)(up to 39 months)
- Number of participants per reason for treatment discontinuation (ribociclib and abemaciclib cohorts)(up to 39 months)
- Type of subsequent anti-neoplastic therapies (ribociclib and abemaciclib cohorts)(up to 39 months)
- Time to subsequent anti-neoplastic therapy (ribociclib and abemaciclib cohorts)(up to 39 months)
- Participants' expectations regarding therapy, side effects and management (ribociclib and abemaciclib cohorts)(baseline)
- Participants' treatment satisfaction (ribociclib and abemaciclib cohorts)(up to 24 months)
- Number of participants per Baseline parameters(baseline)
- Reasons for treatment decision by treating physician(baseline)
- Patients' individual perception of risk of recurrence and treatment decision(baseline)
- Invasive disease-free survival (iDFS) (ribociclib cohort)(12 and 24 months)
- Invasive breast cancer-free survival (iBCFS) (ribociclib cohort)(12, 24 and 36 months)
- Recurrence-free survival (RFS) (ribociclib cohort)(12, 24 and 36 months)
- Distant disease-free survival (DDFS) (ribociclib cohort)(12, 24 and 36 months)
- Incidence and severity of adverse events (ribociclib cohort)(up to 36 months)
- Dose modification rates (ribociclib cohort)(up to 36 months)
- Time to discontinuation (TTD) (ribociclib cohort)(up to 36 months)
- Treatment interruption rates (ribociclib cohort)(up to 36 months)
- Discontinuation rates (ribociclib cohort)(up to 36 months)
- Quality of life by EORTC QLQ-C30 (ribociclib and abemaciclib cohorts)(up to 39 months)
- Quality of life by EORTC QLQ-BR42 (ribociclib and abemaciclib cohorts)(up to 39 months)
- Quality of life by HADS D (ribociclib and abemaciclib cohorts)(up to 39 months)
- Participant compliance as assessed by the Medication Adherence Report Scale (MARS-D) (ribociclib and abemaciclib cohorts)(up to 36 months)
- Participant compliance as assessed by a physician adherence rating (ribociclib cohort)(up to 36 months)
- Participant compliance as assessed by neutrophil count (ribociclib cohort)(up to 36 months)
- Impact of type and change of treatment facility and health care professionals involved in treatment management on participant compliance assessed by MARS-D (ribociclib cohort)(up to 36 months)
- Impact of digital health solutions applied in clinical routine on participant compliance assessed by MARS-D (ribociclib cohort)(up to 36 months)
- Socio-economic status of participants measured by WPAI-GH (ribociclib and abemaciclib cohorts)(up to 39 months)
- Number of participants per reason for treatment discontinuation (ribociclib and abemaciclib cohorts)(up to 39 months)
- Type of subsequent anti-neoplastic therapies (ribociclib and abemaciclib cohorts)(up to 39 months)
- Time to subsequent anti-neoplastic therapy (ribociclib and abemaciclib cohorts)(up to 39 months)
- Impact of an active participation of the participant in the treatment decision on subsequent participant compliance measured by MARS-D (ribociclib cohort)(up to 36 months)
- Impact of participants' fear of cancer recurrence on participant compliance measured by MARS-D (ribociclib cohort)(up to 36 months)
- Participants' expectations regarding therapy, side effects and management (ribociclib and abemaciclib cohorts)(baseline)
- Participants' treatment satisfaction (ribociclib and abemaciclib cohorts)(up to 24 months)