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Recruiting NCT07243002

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

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters: A Hybrid Study With Prospective Patient-reported Outcomes and Retrospective Clinical Chart Review.

Overview

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.

Detailed 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

Primary outcome measures

  • Invasive disease-free survival (iDFS) [Time frame: 36 months]
  • Distant disease-free survival (DDFS) [Time frame: 36 months]
Secondary outcome measures (12)
  • Adherence to ribociclib + ET assessed using the MARS-5 tool [Time frame: Up to approximately 36 months]
  • Adherence to ribociclib + ET assessed using bespoke questions. [Time frame: Up to approximately 36 months]
  • Treatment satisfaction with ribociclib + ET assessed using bespoke questions. [Time frame: Up to approximately 36 months]
  • Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-C30. [Time frame: Up to approximately 36 months]
  • Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-BR42. [Time frame: Up to approximately 36 months]
  • Changes in Long Term Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using bespoke questions. [Time frame: Up to approximately 36 months]
  • Work productivity measured using WPAI [Time frame: Up to approximately 36 months]
  • Patients' experience of treatment in HR+/HER2- stage II and III eBC patients treated with ribociclib + ET [Time frame: Up to approximately 12 months]
  • Work productivity in HR+/HER2- stage II and III eBC patients treated with ribociclib + ET using bespoke questions. [Time frame: Up to approximately 36 months]
  • Persistence to ribociclib + ET [Time frame: Up to approximately 36 months]
  • Distant disease-free survival [Time frame: At 12, 24 and 36 months]
  • Overall survival [Time frame: At 12, 24 and 36 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United Kingdom · 1 center
  • Novartis Investigative Site — London

Identifiers

NCT: NCT07243002 · CLEE011O12005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗