At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 52 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at real-world outcomes and experiences among people who started treatment with ribociclib or abemaciclib early after being approved. It focuses on people with breast cancer. The study is run by Novartis Pharmaceuticals.
Who can take part
- Adults aged 18 or over (or the local legal age of consent) at the time of breast cancer diagnosis
- Diagnosed with breast cancer
- Cancer stage II or III, based on American Joint Committee on Cancer (AJCC) criteria
- Started additional (adjuvant) treatment with ribociclib or abemaciclib, with endocrine therapy (hormone therapy), within 14 days before joining the study
- Cancer tested positive for hormone receptors (oestrogen receptor and/or progesterone receptor)
- Cancer tested negative for HER2 (a protein that helps cancer cells grow)
Who may not be able to
- People whose breast cancer came back (locally or further away in the body) before starting ribociclib or abemaciclib
- People who took part in clinical trials with study drugs during the 12 months before joining
- People who cannot physically or mentally understand the study requirements or complete the study forms without help from a legal representative
What taking part involves
- • Taking ribociclib or abemaciclib, as approved locally, together with endocrine therapy (hormone therapy)
Time commitment: Not stated — ask the trial team about study visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 3,000
- Started
- 2025-12-15
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • Clinical study - 3,000 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast cancer
Where?
- • London - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Males or females.
- ✓Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th...
- ✓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 after surgery therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET...
Who cannot take part
- ✗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.,...
- ✗Patients physically/mentally incapable of understanding the study requirements or fulfilling data collection...
See the full criteria
Where Is This Study? (1 UK site)
Novartis Investigative Site
London SW3 6JJ, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT