Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.
Recruiting · NCT07243002 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
- Have initiated adjuvant therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET (within 14 days prior to enrollment).
- Have HR+ status, as determined by the closest biomarker test on or before the adjuvant therapy initiation date:
- Tested positive for estrogen receptor (ER+), or
- Tested positive for progesterone receptor (PR+), or
- Tested positive for both.
- Tested negative for HER2 (HER2-) using the closest biomarker test on or before the adjuvant therapy initiation date.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Novartis Investigative Site - London, United Kingdom