IBCSG 67-22 PREcoopERA: A Window-of-Opportunity trial of giredestrant +/- triptorelin vs. anastrozole + triptorelin in premenopausal patients with ER-positive/HER2-negative early breast cancer.
This study, called IBCSG 67-22 PREcoopERA, is for premenopausal women who have an early form of breast cancer that is sensitive to hormones (ER-positive) but not affected by a protein called HER2. Researchers want to compare a new hormone medicine called giredestrant, either alone or with triptorelin, against a standard treatment of anastrozole plus triptorelin. The main goal is to see how much these treatments reduce the growth rate of cancer cells (measured by something called Ki-67) before surgery. This 'window-of-opportunity' trial aims to understand which approach works best at slowing the cancer down, potentially leading to better treatments in the future. It's a Phase II study, meaning it's exploring how well these treatments work.
At a glance
What is this study about?
This study, called IBCSG 67-22 PREcoopERA, is specifically designed for women who are still having periods (premenopausal) and have been diagnosed with early breast cancer. This type of breast cancer is known to be sensitive to hormones, meaning hormones in the body can fuel its growth. It's also HER2-negative, which means it doesn't have too much of a protein called HER2.
The main aim of this research is to test different hormone treatments. Some women will receive a new drug called giredestrant, either by itself or combined with another drug called triptorelin. Other women will receive a standard treatment which is anastrozole plus triptorelin. The study wants to find out which of these treatments is most effective at slowing down the cancer cells' growth before any surgery. They do this by looking at changes in a marker called Ki-67 in the tumour.
Understanding how these treatments affect cancer growth early on – during a short 'window of opportunity' before surgery – can help doctors find better ways to treat this type of breast cancer in the future. This is a Phase II study, which means it's one of the earlier steps in testing new medicines, focusing on how well they work and their safety. The hope is to improve treatment options for women with this specific type of breast cancer.
Key takeaways
- Tests new hormone treatments for early breast cancer.
- Specifically for women who are premenopausal.
- Aims to see which treatment best slows cancer growth before surgery.
- Compares giredestrant to standard anastrozole treatment.
- Helps doctors find better future treatments for this type of cancer.
Who may be eligible?
This study is looking for women who are at least 18 years old. You must still be having your period, meaning you haven't gone through menopause yet.
Your breast cancer needs to be early-stage and have specific features: it must be 'ER-positive,' which means its growth is affected by hormones, and 'HER2-negative,' meaning it doesn't have too much of another protein called HER2. Other specific medical details will be checked by the study team to confirm you're a good fit.
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 old or older?
- Are you still having your periods (premenopausal)?
- Have you been diagnosed with early breast cancer that is ER-positive?
- Is your breast cancer also HER2-negative?
What does participation involve?
If you join this study, you would first have a small sample (biopsy) taken from your tumour. Then, you would receive one of the study treatments for a short period before your planned surgery. During this time, you would have regular visits to the clinic for assessments, which might include blood tests and physical examinations, to check how you're responding to the treatment and to monitor your health. Your medication would be provided as part of the study. After a set period of treatment, you would have another biopsy of the tumour, usually as part of your planned surgery. The total duration of your active participation in the study, including treatment and follow-up assessments, would be discussed with you by the study team.
Potential risks and benefits
Locations (7)
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Common questions
What is 'ER-positive/HER2-negative' breast cancer?
This means your cancer cells grow in response to hormones, but they don't have too much of a protein called HER2.
What does 'premenopausal' mean?
It means you are still having regular periods and haven't gone through menopause yet.
What is 'Ki-67'?
Ki-67 is a marker that doctors measure to see how quickly cancer cells are growing and dividing.
What is a 'window-of-opportunity' trial?
This is a short study where treatment is given for a brief time before surgery to see how it affects the tumour cells.
Why are they using different drug combinations?
Researchers want to compare new treatments against standard ones to find the most effective way to slow down cancer growth.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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