Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals
About this trial
This non-interventional study (NIS) aims to evaluate effectiveness, persistence, treatment patterns, adverse events (AEs), and patient-reported experience (including adherence, treatment satisfaction, health-related quality of life \[HRQoL\], work productivity, and etc.), among HR+/HER2- stage II and III eBC patients treated with ribociclib + ET, and to evaluate AEs and patients-reported experience among HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET, as per local label.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females.
Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th Revision, Clinical Modification (ICD-9-CM 174.xx, 175.xx/ICD-10-CMC50.xx).
Aged ≥18 years (or local legal age of consent) at the date of initial breast cancer diagnosis.
Patients with anatomic staging II and III as determined using American Joint Committee on Cancer (AJCC) Criteria.
Disqualifiers
Patients with local or distant breast cancer recurrence before the ribociclib/abemaciclib initiation date.
Patients enrolled in clinical trials (receiving treatment with clinical study drugs in any setting, i.e., neoadjuvant, adjuvant, local/regional, metastatic) during the 12-month baseline period.
Patients physically/mentally incapable of understanding the study requirements or fulfilling data collection instruments and require the support of a legally authorized representative.
Trial population
Patients with early breast cancer stage II or III, ER+ or PR+ (or both) and HER2-, treated per standard of care with ribociclib plus Endocrine Therapy (N=2650) or abemaciclib plus Endocrine Therapy (N=250).
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsGroup A: Ribociclib arm
Group B: Abemaciclib arm
Trial outcomes
Primary outcomes
1
Invasive disease-free survival (iDFS)
iDFS is defined as time to first invasive breast cancer recurrence (ipsilateral, contralateral, local/regional, distant), new primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause.
Time frame
36 months2
Distant disease-free survival (DDFS)
Distant disease-free survival (DDFS) is defined as time to first distant recurrence, second primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause. This will be assessed based on STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials) and collected retrospectively from patient chart.
Time frame
36 monthsSecondary outcomes
1
Adherence to ribociclib + ET assessed using the MARS-5 tool
The MARS-5 (Medication Adherence Report Scale) is a 5 item questionnaire designed to assess patient adherence to treatment. Score is ranging from 1 (always) to 5 (never) for each item. The total score ranges from 5 to 25, where a higher MARS-5 score indicates higher adherence. One item assesses unintentional non-adherence, and four items assess intentional non-adherence.
Time frame
Up to approximately 36 months2
Adherence to ribociclib + ET assessed using bespoke questions.
6 bespoke questions as to adherence have been added to capture key behavior patterns (ie, use of other products, cost, schedule, time, access to medication and convenience). Score is ranging from 1 (always) to 5 (never) for each item.
Time frame
Up to approximately 36 months3
Treatment satisfaction with ribociclib + ET assessed using bespoke questions.
Treatment satisfaction will be assessed using 8 bespoke questions, focusing on key domains such as expectations, feelings about side effects, management of side effects, and overall satisfaction. Responses are scored on a 5-point Likert scale ranging 1 (always) to 5 (never) depending on satisfaction level.
Time frame
Up to approximately 36 months4
Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-C30.
Health related quality of life will be assessed with the EORTC QLQ c30, which was designed to measure psychical, social, emotional, cognitive functions, symptom and health status in individuals with cancer. Item 1-28 are scored on a 4 point Liker t scale (1 + not at all, to 4 + very much). Item 29 and 30 are scored on a 7 point numerical rating scale (from 1 + very poor to 7 + Excellent). Raw scored are transformed and standardized with scores ranging from 0 to 100. A higher score represents either a better functioning, a higher level of Quality of life or a worse (higher) level of symptomatology.
Time frame
Up to approximately 36 monthsSponsors and contacts
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Source ClinicalTrials.gov