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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

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

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to ribociclib + ET assessed using the MARS-5 tool	The MARS-5 (Medication Adherence Report Scale) is a 5 item questionnaire designed to assess patient adherence to treatment. Score is ranging from 1 (always) to 5 (never) for each item. The total score ranges from 5 to 25, where a higher MARS-5 score indicates higher adherence. One item assesses unintentional non-adherence, and four items assess intentional non-adherence.	Up to approximately 36 months
Adherence to ribociclib + ET assessed using bespoke questions.	6 bespoke questions as to adherence have been added to capture key behavior patterns (ie, use of other products, cost, schedule, time, access to medication and convenience). Score is ranging from 1 (always) to 5 (never) for each item.	Up to approximately 36 months
Treatment satisfaction with ribociclib + ET assessed using bespoke questions.	Treatment satisfaction will be assessed using 8 bespoke questions, focusing on key domains such as expectations, feelings about side effects, management of side effects, and overall satisfaction. Responses are scored on a 5-point Likert scale ranging 1 (always) to 5 (never) depending on satisfaction level.	Up to approximately 36 months
Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-C30.	Health related quality of life will be assessed with the EORTC QLQ c30, which was designed to measure psychical, social, emotional, cognitive functions, symptom and health status in individuals with cancer. Item 1-28 are scored on a 4 point Liker t scale (1 + not at all, to 4 + very much). Item 29 and 30 are scored on a 7 point numerical rating scale (from 1 + very poor to 7 + Excellent). Raw scored are transformed and standardized with scores ranging from 0 to 100. A higher score represents either a better functioning, a higher level of Quality of life or a worse (higher) level of symptomatology.	Up to approximately 36 months
Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-BR42.	The EORTC QLQ BR42 is a specific breast cancer questionnaire to be used in conjunction with the EORTC QLQ c30. Items were designed to measure treatment side effect, symptoms, body image sexual functioning, breast satisfaction, future perspective, sexual enjoyment and weight gain. All items are scored on a 4-point Likert scale (from 1 = Not at all, to 4 = Very much). Items and domains are transformed and scores range between 0-100. Higher scores represent higher (better) functioning or higher levels (worse) symptomatology .	Up to approximately 36 months
Changes in Long Term Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using bespoke questions.	Health related quality of life assessed using bespoke questions to evaluate long term quality of life. Three bespoke questions were designed to measure long term QoL. The questions will be scored individually from 1 (Always) to 5 (Never), scores will be reversed as needed. There are also 2 bespoke questions to assess the impact on cognitive functions, both are scored individually from 1 (Always) to 5 (Never) with higher score indicating better cognitive functions.	Up to approximately 36 months
Work productivity measured using WPAI	This is assessed using the WPAI tool, focusing on key aspects such as absenteeism, presenteeism, work productivity loss, activity impairment, and long-term impact of side effects on work activity. This questionnaire has 6 questions, which are used to calculate 4 types of scores, which are absenteeism (work time missed), presenteeism (impairment at work/reduced on the job effectiveness), work productivity loss (overall work impairment), and activity impairment. The scores are expressed in percentage with higher numbers indicating greater impairment and less productivity.	Up to approximately 36 months
Patients' experience of treatment in HR+/HER2- stage II and III eBC patients treated with ribociclib + ET	Patients' experience of treatment assessed using qualitative interviews conducted in the sub-cohort of ribociclib + ET in the US only.	Up to approximately 12 months
Work productivity in HR+/HER2- stage II and III eBC patients treated with ribociclib + ET using bespoke questions.	One bespoke question is used to evaluate impact of side effect on work productivity. The question is rated from 1 (always) to 5 (never) with higher score indicating better situation (reduced impact on work).	Up to approximately 36 months
Persistence to ribociclib + ET	Proportion of patients who continue (persist) and discontinue ribociclib + ET.	Up to approximately 36 months
Distant disease-free survival	Distant disease-free survival (DDFS) is defined as the time to first distant recurrence, second primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause.	At 12, 24 and 36 months
Overall survival	Overall survival (OS) is defined as time to death from breast cancer, non-breast cancer or unknown cause.	At 12, 24 and 36 months
Distant recurrence-free survival	Distant recurrence-free survival (DRFS) is defined as the time to first distant recurrence or death from breast cancer, non-breast cancer or unknown cause.	At 12, 24 and 36 months
Invasive disease-free survival	Invasive disease-free survival (iDFS) is defined as the 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.	At 12, 24 and 36 months
Invasive breast cancer-free survival	Invasive breast cancer-free survival (iBCFS) is defined as time to first invasive breast cancer recurrence (ipsilateral, local/regional, contralateral or distant) or death from breast cancer, non-breast cancer or unknown cause.	At 12, 24 and 36 months
Patient and tumor characteristics at/around recurrence for HR+/HER2- stage II and III eBC patients treated with ribociclib + ET.	Patient characteristics and tumor characteristics at/around recurrence, as available from chart.	From index date until death, lost to follow-up, end of study period, or enrollment in clinical trials, whichever occurs first. The maximum follow-up time is expected to be up to 54 months
AEs affecting HR+/HER2- stage II and III eBC patients treated with ribociclib + ET	AEs will be collected retrospectively from chart with their grading.	Every 6 months until death, lost to follow-up, end of study period, or enrollment in clinical trials, whichever occurs first. Up to approximately 54 months
Number of participants by treatment patterns assessed in both the adjuvant and metastatic settings	Adjuvant setting: neoadjuvant, adjuvant, and any chemotherapy, type of primary site surgery, neoadjuvant ET, neoadjuvant chemotherapy and/or ET, type of ET, and TTD from adjuvant ribociclib initiation.; Metastatic setting: number of patients who receive 1L, most common treatment regimens at 1L, and TTD from the start of 1L following the first metastatic recurrence	From index date until death, lost to follow-up, end of study period, or enrollment in clinical trials, whichever occurs first. The maximum follow-up time is expected to be up to 54 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): May 30, 2030
• Study Completion (Estimated): May 30, 2030

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Non interventional study; ribociclib, abemacicblib
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CLEE011O12005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO