RecruitingOBSERVATIONAL

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

This study is gathering information on real-life experiences of people with early-stage breast cancer who are taking new medicines called ribociclib or abemaciclib, combined with hormone therapy. It's for people whose cancer is hormone-receptor positive and HER2-negative. We want to understand how well these treatments work, if people stick with them, what side effects they have, and how they affect their daily life and quality of life. This isn't a typical clinical trial where new treatments are tested; instead, it's observing people who are already receiving these approved medicines as part of their usual care. The aim is to get a better picture of how these treatments are used and experienced outside of strict trial conditions.

At a glance

Status

Recruiting

Sponsor

Novartis Pharmaceuticals

Enrolment target

3,000

Start

15 Dec 2025

Estimated completion

30 May 2030

Breast Cancer

What is this study about?

This study is designed to understand how new breast cancer treatments, ribociclib and abemaciclib, are used and how people experience them in their everyday lives. These medicines are given alongside hormone therapy for early-stage breast cancer that is hormone-receptor positive and HER2-negative (meaning the cancer cells have certain features that respond to these specific treatments).

Unlike traditional clinical trials where new drugs are tested, this study observes people who are already receiving these approved medicines as part of their standard care. We want to learn more about how well the treatments work in a real-world setting, whether people continue taking them, what side effects they experience, and how the treatments affect their day-to-day life and overall well-being. This includes understanding their satisfaction with treatment and how it impacts their ability to work or go about their usual activities.

The study will look back at some of the participant's past medical records and also collect new information as they continue their treatment. This includes asking people to fill out questionnaires about their health and experiences. The information gathered will help doctors and researchers understand more about these important breast cancer treatments and how they affect people's lives.

Key takeaways

This study collects real-world information on approved breast cancer treatments.
It focuses on early-stage, hormone-receptor positive, HER2-negative breast cancer.
Participation involves sharing experiences and health information, not changing treatment.
The goal is to understand how treatments work and affect quality of life in everyday settings.
Your contribution helps improve understanding and care for future patients.
You can stop participating at any time.

Who may be eligible?

To take part in this study, you need to be an adult (18 years or older) who has been diagnosed with early-stage breast cancer (stage II or III).

The breast cancer must be hormone-receptor positive (meaning tests show it responds to hormones) and HER2-negative (meaning it doesn't have too much of a protein called HER2). You must have started taking either ribociclib or abemaciclib with hormone therapy for this condition recently.

You wouldn't be able to join if your breast cancer has come back or spread before starting these medicines, or if you're currently in another clinical trial where you're receiving experimental treatments. Also, if you're unable to understand the study or fill out questionnaires, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have early-stage breast cancer (stages II or III)?
Has your breast cancer been tested as hormone-receptor positive and HER2-negative?
Have you recently started taking ribociclib or abemaciclib with hormone therapy?
Are you not currently involved in another clinical trial with experimental treatments?

Answer every question to see your result.

What does participation involve?

This study is collecting information from people already receiving standard treatment for breast cancer, so you wouldn't be given any experimental medicines. Generally, taking part means allowing researchers to look at some of your past medical notes and periodically filling out questionnaires about your health, feelings, and experiences with your treatment. You might also be asked to take part in interviews. The study will observe your treatment journey for a period, gathering information on how you're feeling, how well the treatment is working for you, and any side effects you might have. You would continue to receive your care as usual from your own doctor.

Potential risks and benefits

The main benefit of taking part is contributing valuable real-world information that can help doctors and researchers better understand these breast cancer treatments, potentially improving care for others in the future. As you are already receiving approved treatments, there are no additional medical risks from the study itself. The primary risks involve the time and effort required to fill out questionnaires or attend interviews, and the possibility that information about you could be seen by researchers. However, all personal information will be kept as private as possible. Remember, you can choose to stop participating in the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Novartis Investigative Site
Verified postcode
London, United Kingdom· Recruiting

Common questions

What kind of breast cancer is this study for?

This study is for early-stage breast cancer (stage II or III) that is hormone-receptor positive and HER2-negative.

What medicines are being looked at in this study?

The study is looking at ribociclib and abemaciclib, used with hormone therapy, which are approved treatments for this type of breast cancer.

Do I have to take new medicines if I join this study?

No, this study is for people already taking these medicines as part of their usual care. You wouldn't be given any new or experimental treatments.

What does 'non-interventional' mean?

It means the study observes what's happening in real life without changing your treatment or how your doctor cares for you. It's about gathering information, not testing new things.

Will my personal details be kept private?

The researchers will do their best to keep your personal information private and use it only for the study's purposes.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com +41613241111 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.