Real-world outcomes and patient experiences with early use of ribociclib

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.

This project will see how people with HR+/HER2- stage II–III early breast cancer do on ribociclib plus endocrine therapy and will also gather patient-reported experiences for those on abemaciclib plus endocrine therapy.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 1 site (London)
• Trial ID: NCT07243002 on ClinicalTrials.gov

What this trial studies

This is a multi-center, multi-country, non-interventional hybrid study of adults with HR+/HER2- stage II–III early breast cancer treated with ribociclib plus endocrine therapy or, exploratory, abemaciclib plus endocrine therapy as given in routine care. The design combines retrospective extraction of electronic health record data with prospective collection of validated patient-reported outcome questionnaires, bespoke questions, and qualitative interviews. Key measures include effectiveness, treatment persistence and patterns, adverse events, adherence, treatment satisfaction, health-related quality of life, and work productivity. No formal statistical comparison between the ribociclib and abemaciclib cohorts is planned.

Who should consider this trial

Good fit: Adults (≥18) with HR+/HER2- stage II or III early breast cancer who have started adjuvant ribociclib or abemaciclib in combination with endocrine therapy within about 14 days before enrollment are the intended participants.

Not a fit: Patients with metastatic (stage IV) disease, HER2-positive tumors, or those not receiving ribociclib or abemaciclib with endocrine therapy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study may help patients and clinicians understand real-world tolerability, adherence, and quality-of-life impacts of adding ribociclib to endocrine therapy in early HR+/HER2- breast cancer.

How similar studies have performed: Clinical trials and real-world reports of CDK4/6 inhibitors in HR+/HER2- breast cancer have shown meaningful benefits in certain settings, while adjuvant data and real-world experience continue to evolve.

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.

Where this trial is running

London

• Novartis Investigative Site — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Breast Cancer; ribociclib, abemacicblib; Non interventional study