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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Novartis Investigative Site
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.