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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov