Breast CancerREPOWERNCT07243002
Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 3,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2025to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United Kingdom1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
London, SW3 6JJ
About this study
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.
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.
Read the 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
- Conditions
- Breast Cancer
- Keywords
- ribociclib, abemacicblib, Breast Cancer, Non interventional study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 36 months
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to approximately 36 months
Persistence to ribociclib + ET
Proportion of patients who continue (persist) and discontinue ribociclib + ET.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Dec 2025
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243002
- Sponsor's protocol ID
- CLEE011O12005
- Acronym
- REPOWER
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07243002
- Acronym / sponsor ID
- REPOWER / CLEE011O12005
- Conditions
- Breast Cancer
- Keywords
- ribociclib, abemacicblib, Breast Cancer, Non interventional study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Invasive disease-free survival (iDFS)
Time frame: 36 months
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.
Distant disease-free survival (DDFS)
Time frame: 36 months
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.
18 secondary outcomes
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
Distant recurrence-free survival
Time frame: At 12, 24 and 36 months
Invasive disease-free survival
Time frame: At 12, 24 and 36 months
Invasive breast cancer-free survival
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease-free survival (iDFS) (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.