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

NCT07243002 | Recruiting

• 1 other identifier: CLEE011O12005
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

ribociclib, abemacicblib; Breast Cancer; Non interventional study

Outcome Measures

Primary Outcomes (2)

• Invasive disease-free survival (iDFS)

  iDFS is defined as time to first invasive breast cancer recurrence (ipsilateral, contralateral, local/regional, distant), new primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause.

  36 months

• Distant disease-free survival (DDFS)

  Distant disease-free survival (DDFS) is defined as time to first distant recurrence, second primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause. This will be assessed based on STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials) and collected retrospectively from patient chart.

  36 months

Secondary Outcomes (18)

• Adherence to ribociclib + ET assessed using the MARS-5 tool

  Up to approximately 36 months

• Adherence to ribociclib + ET assessed using bespoke questions.

  Up to approximately 36 months

• Treatment satisfaction with ribociclib + ET assessed using bespoke questions.

  Up to approximately 36 months

• Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-C30.

  Up to approximately 36 months

• Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-BR42.

  Up to approximately 36 months

Study Arms (2)

Ribociclib arm

Patient treated with ribociclib and Endocrine Therapy (ET) per standard of care

Abemaciclib arm

Patient treated with abemaciclib and Endocrine Therapy (ET) per standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early breast cancer stage II or III, ER+ or PR+ (or both) and HER2-, treated per standard of care with ribociclib plus Endocrine Therapy (N=2650) or abemaciclib plus Endocrine Therapy (N=250).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

London, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 21, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): May 30, 2030
• Study Completion (Estimated): May 30, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)