Active not recruitingPHASE3INTERVENTIONAL

Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

This study is for women diagnosed with early breast cancer that is hormone receptor-positive and HER2-negative, and considered to be at ‘intermediate risk’. Researchers want to find out if combining a drug called ribociclib with hormone therapy is a better treatment option for these women compared to standard chemotherapy. This trial aims to personalise treatment, meaning giving the right treatment to the right person. If successful, this could mean more effective treatment with potentially fewer side effects for women with this specific type of breast cancer. Participants will be carefully monitored throughout the study to ensure their safety and track how well the treatments work.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

West German Study Group

Enrolment target

1,684

Start

02 Jul 2019

Estimated completion

31 Jul 2027

Breast Cancer Female

What is this study about?

This study is looking into a new way to treat women who have been diagnosed with a specific type of early breast cancer. This particular type of breast cancer is called 'hormone receptor-positive' and 'HER2-negative'. For these patients, doctors sometimes describe their cancer as being at an 'intermediate risk'. The main goal of this research is to see if a combination of two treatments – a drug called ribociclib, given along with standard hormone therapy – works better than the usual chemotherapy treatment for this group of women.

Over the years, doctors have been trying to make cancer treatments more personal. This means trying to find the best treatment for each individual patient, rather than a one-size-fits-all approach. This study is part of a larger research effort that has been looking at how to do this for breast cancer, checking if early signs can tell us which treatments might work best for certain types of tumours. The hope is to give you a treatment that is most likely to help, while also trying to reduce side effects.

By comparing ribociclib plus hormone therapy to chemotherapy, the study aims to understand if this new combination offers extra benefits for women with intermediate-risk breast cancer. This could mean a more effective treatment, and potentially a different set of side effects than chemotherapy, which might be easier to manage for some patients. The overall aim is to improve the chances of successful treatment and the quality of life for women with this type of breast cancer.

Key takeaways

This study is for women with a specific type of early breast cancer (hormone receptor-positive, HER2-negative).
It compares a new treatment (ribociclib + hormone therapy) to standard chemotherapy.
The goal is to find a more personalised and potentially better treatment for an 'intermediate risk' group.
Participation involves screening, receiving one of the study treatments, and regular check-ups.
Your safety will be closely monitored, and you can withdraw from the study at any time.
This research aims to improve future treatment options for breast cancer patients.

Who may be eligible?

This study is specifically looking for women who have been diagnosed with early breast cancer. You need to be 18 years old or older. The cancer must be 'hormone receptor-positive' and 'HER2-negative', which your doctors will be able to confirm from tests on your tumour.

The study is for women who are either past menopause, or who are still having periods but meet certain conditions, such as having a negative pregnancy test. Your local treatment for breast cancer, like surgery, would need to follow current guidelines. Importantly, the doctors need to confirm that your cancer has not spread to other parts of your body, and that it falls into a specific 'intermediate risk' category for this type of breast cancer.

The researchers will also need to have a sample of your tumour tissue from when you were first diagnosed. This helps them understand more about your cancer and make sure you're a good fit for the study.

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 female and aged 18 or older?
Do you have early breast cancer that is hormone receptor-positive and HER2-negative?
Has your doctor confirmed your cancer is 'intermediate risk' according to study definitions?
Have you had local treatment for your breast cancer (or is it planned)?
Has it been confirmed that your cancer has not spread to other parts of your body?
Are you post-menopausal, or if not, are you willing to take a pregnancy test and are not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to make sure you meet all the requirements. This will involve some medical checks and tests. Once you are confirmed to be eligible, you will be randomly assigned to receive either the ribociclib and hormone therapy combination or the standard chemotherapy treatment, followed by hormone therapy. You won't be able to choose which treatment you get, as this is decided by chance to make the study fair.

You will have regular visits to the clinic for check-ups, blood tests, and to make sure you are feeling well and that the treatment is working as expected. These visits will also be used to manage any side effects you might experience. The ribociclib and hormone therapy are taken as tablets, and the chemotherapy will be given as advised by your doctor for a certain period. After the main treatment, there will be a period of follow-up where doctors will continue to monitor your health over time to see the long-term effects of the treatment. The total duration of the study, including follow-up, could last several years.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and potentially effective treatment that might have different side effects compared to standard options. However, there are also potential risks involved, as with any medical treatment. These risks are carefully monitored by the study team, and you will be fully informed about them before you agree to participate. You will also have regular check-ups to monitor your health. It is very important to remember that participating in this study is entirely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (86)

Ost-Alb Klinikum Brustzentrum
Verified postcode
Aalen, Germany
Stadtklinik Baden-Baden Brustzentrum
Verified postcode
Baden-Baden, Germany
Kreiskliniken Böblingen Klinikum Böblingen Frauenklinik
Verified postcode
Böblingen, Germany
Uniklinikum Freiburg Frauenklinik
Verified postcode
Freiburg im Breisgau, Germany
Praxis für interdisziplinäre Onkologie & Hämatologie GbR Praxis am Diakonieklinikum
Verified postcode
Freiburg im Breisgau, Germany
SLK-Kliniken-Heilbronn Frauenklinik
Verified postcode
Heilbronn, Germany
Klinikum Ludwigsburg Klinik für Frauenheilkunde u. Geburtshilfe
Verified postcode
Ludwigsburg, Germany
Universitätsklinikum Tübingen Universitäts-Frauenklinik
Verified postcode
Tübingen, Germany
Universitätsfrauenklinik Ulm Frauenheilkunde und Geburtshilfe
Verified postcode
Ulm, Germany
GRN Klinik Weinheim Gynäkologie
Verified postcode
Weinheim, Germany
Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Brustzentrum
Verified postcode
Munich, Germany
Rotkreuzkliniken München Frauenklinik - Gynäkologie
Verified postcode
München, Germany

Common questions

What does 'intermediate risk' breast cancer mean?

It means your breast cancer has certain features that place it in a middle category regarding its chance of coming back. It’s not considered low risk, but not high risk either.

What is ribociclib?

Ribociclib is a type of targeted drug that works by blocking certain proteins in cancer cells, which can help stop them from growing and dividing. It is often used with hormone therapy for some breast cancers.

What is 'hormone therapy'?

Hormone therapy is a treatment that either lowers the amount of hormones in your body or blocks their action, because some breast cancers use hormones to grow.

Will I definitely get the new treatment if I join?

No, because it’s a study, you'll be randomly assigned to either receive the new treatment combination or the standard chemotherapy. This is done by chance, like flipping a coin, to ensure a fair comparison.

What if I experience side effects?

The study team will closely monitor you for any side effects, and they will provide care and advice on how to manage them. Your safety and well-being are a top priority.