The PREcoopERA clinical trial is a window-of-opportunity (WOO) trial for premenopausal women diagnosed with hormone-sensitive, HER2-negative, early-stage breast cancer that tests positive for the biomarker Ki-67.
A window-of-opportunity trial is a special type of clinical research that is conducted in a short period of time or window of opportunity, usually between diagnosis and surgery. In the trial, the drugs giredestrant, triptorelin and anastrozole are tested in three different groups. We want to find out which study drug is best at stopping the division and growth of breast cancer cells. To this end, we will examine the levels of the biomarker Ki-67 in breast cancer samples
Aim of the study
As part of the study, the drugs giredestrant, triptorelin and anastrozole are being tested in three different groups (see below).
We want to find out which study drug is best at stopping the division and growth of breast cancer cells. To this end, we will examine the levels of the biomarker Ki-67 in breast cancer samples
Who can take part?
Premenopausal women diagnosed with hormone-sensitive, HER2-negative, early-stage breast cancer that tests positive for the biomarker Ki-67
Procedure
In the PREcoopERA study, participants are randomly divided into groups. This is called randomization and is important to ensure that the study results are reliable. Each group receives a different treatment. There are 3 groups in this study:
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Group A: Giredestrant, one capsule of 30 mg, to be taken orally (swallowed) once a day.
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Group B: Giredestrant, one 30 mg capsule, taken orally (swallowed) once daily, plus triptorelin, at a dose of 3.75 mg administered by injection (syringe) at the study visit on day 1.
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Group C: Anastrozole, one 1 mg tablet, taken orally (swallowed) once daily, plus triptorelin, at a dose of 3.75 mg administered by injection (syringe) at the study visit on day 1.
Both you and your study doctor will be informed which treatment you have been assigned to.
Compensation
none
Original study name
A window-of-opportunity study of hormone therapy in premenopausal women with ER-positive/HER2-negative early breast cancer
BASEC number
2023-01421
Sponsors