Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters. (REPOWER)

Novartis

Status

Enrolling

Conditions

Breast Cancer

Study type

Observational

Funder types

Industry

Identifiers

NCT07243002

CLEE011O12005

Details and patient eligibility

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.

Full description

This will be a multi-center, multi-country, observational, non-interventional, hybrid study among HR+/HER2- stage II or III eBC patients treated with ribociclib + ET or abemaciclib + ET, as per local label in routine clinical care settings.

The study will include a retrospective and a prospective part. The hybrid design will combine retrospective data extraction from patients' EHRs and prospective data collection from validated PRO questionnaires, bespoke questions, and qualitative interviews, to provide comprehensive data on the patient population.

The exploratory objectives will assess HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET. No formal comparison between the cohorts will be made

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.