Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests
This study aims to find out if using a genetic test, called Prosigna®, can help doctors decide the best treatment for premenopausal women who have hormone-dependent breast cancer. Currently, many of these women receive chemotherapy, which can cause significant side effects. The study will compare whether using the test to guide treatment (either chemotherapy plus hormone therapy, or hormone therapy alone) is as effective as the current standard approach, which often includes chemotherapy. Researchers also want to understand how this approach affects patients' quality of life, costs, and their thoughts on potentially reducing treatment. This could help tailor treatments better and reduce harsh side effects for some patients.
At a glance
What is this study about?
If you're a younger woman diagnosed with a common type of breast cancer that's sensitive to hormones (we sometimes call this HR+/HER2- breast cancer), this study might be of interest to you. For many years, treatments for this cancer have included chemotherapy and hormone treatments. While these treatments are good at preventing the cancer from coming back, chemotherapy can be quite challenging, especially for younger women, causing tough side effects that can affect daily life.
For older women with this type of cancer, doctors sometimes use special genetic tests to help them decide if chemotherapy is truly necessary. However, for younger women, chemotherapy is often recommended as standard, even though some might not need it. This study wants to see if using a genetic test called Prosigna® can help sort out who really needs chemotherapy and who might do just as well with hormone therapy alone, which typically has fewer severe side effects. The study aims to make sure that any new approach is just as safe and effective as the current treatments in stopping the cancer from returning.
They will compare two groups of patients: one group will have their treatment decided based on the Prosigna® test results, while the other group will receive the usual standard treatment. The main thing they'll be looking at is how long it takes before the cancer comes back in either group. They also want to understand if reducing chemotherapy affects your quality of life, the costs involved, and how you feel about changes to your treatment plan. Ultimately, the goal is to find ways to give you the most effective treatment with the fewest possible side effects.
Key takeaways
- Aims to safely reduce chemotherapy for some younger women.
- Uses a genetic test to help guide treatment decisions.
- Compares test-guided therapy to standard chemotherapy approaches.
- Focuses on hormone-dependent (HR+/HER2-) breast cancer.
- Studies impact on recurrence, quality of life, and treatment costs.
Who may be eligible?
This study is for women who are 35 years old or older, but have not yet gone through menopause. You must have been recently diagnosed with a specific type of breast cancer that is sensitive to hormones (HR+/HER2- invasive breast cancer).
You would have recently had surgery on your breast and underarm, and the doctors need to be able to get a sample of your tumour to do the Prosigna® genetic test. The size of your tumour and whether it has spread to a few nearby lymph nodes will also be important for deciding if you can join.
Unfortunately, you can't join if you have already gone through menopause, have cancer that has spread widely in the body (Stage IV), have recently had certain other cancers, or if you are pregnant or breastfeeding. Also, if you've already received a lot of cancer treatment before, you won'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 between 35 and roughly 45 years old?
- Have you been diagnosed with HR+/HER2- breast cancer recently?
- Are you premenopausal (meaning you still have periods or haven't gone through menopause yet)?
- Have you had breast and underarm surgery recently (within the last 12 weeks)?
- Do you have a tumour sample available for genetic testing?
What does participation involve?
If you decide to take part, you'll first have some checks to make sure the study is right for you. This will happen up to four weeks before you are officially enrolled. Once you're in, you’ll be randomly assigned to one of two groups: one group will have their treatment guided by the Prosigna® genetic test, which could mean hormone therapy alone, or chemotherapy plus hormone therapy. The other group will receive the standard course of treatment, which is usually chemotherapy plus hormone therapy. Both groups will receive careful follow-up care that is similar to what you would get as standard.
You'll be asked to fill out questionnaires over the next five years. These will help the researchers understand how your quality of life is, how much treatment might cost, and what you think about being in the study. The total duration of your active involvement with questionnaires will be five years, but your treatment and follow-up will be similar to standard care.
Potential risks and benefits
Locations (105)
- Institut Jules BordetVerified postcodeBrussels, Belgium
- Cliniques Universitaires Saint-LucVerified postcodeBrussels, Belgium
- Grand Hôpital de CharleroiVerified postcodeCharleroi, Belgium
- CHU Helora Hôpital de La Louvière - Site JolimontVerified postcodeHaine-Saint-Paul, Belgium
- CHU UCL Namur - Site Sainte ElisabethVerified postcodeNamur, Belgium
- Clinique Saint PierreVerified postcodeOttignies, Belgium
- CHR VerviersVerified postcodeVerviers, Belgium
- Centre Hospitalier d'AuxerreVerified postcodeAuxerre, France
- Sainte Catherine - Institut du Cancer Avignon-ProvenceVerified postcodeAvignon, France
- Centre Hospitalier de la Côte BasqueVerified postcodeBayonne, France
- Centre Hospitalier Simone Veil de BeauvaisVerified postcodeBeauvais, France
- Hôpital de BloisVerified postcodeBlois, France
Common questions
What is hormone-dependent breast cancer?
It's a common type of breast cancer where the cancer cells grow in response to hormones in your body, which helps doctors choose specific hormone-blocking treatments.
What is the Prosigna® genetic test?
It's a test that looks at certain genes in your breast cancer cells to help predict how likely the cancer is to come back and if chemotherapy might be very helpful or not.
Why focus on younger women?
Chemotherapy can have particularly tough side effects for younger women, and this study wants to see if some can safely avoid it while still getting effective treatment.
Will I definitely avoid chemotherapy if I join?
Not necessarily. If you're in the test-guided group, the test will help decide. If you're in the standard treatment group, you'll likely receive chemotherapy as part of the usual care.
What does 'optimised hormone treatment' mean?
It means the best possible hormone therapy, which might include medicines to stop your ovaries from producing hormones (called ovarian suppression), to improve its effectiveness.
How to find out more
Aure Vanhecke
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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