About this trial
The PREcoopERA clinical study is a window-of-opportunity study for premenopausal women diagnosed with hormone-sensitive, HER2-negative early breast cancer that is positive for the biomarker Ki-67.
A window-of-opportunity study is a type of clinical research done over a short period of time, usually between the time of diagnosis and the surgery.
The aim of the PREcoopERA window-of-opportunity study is not to directly test whether a new study drug is effective in treating early-stage breast cancer. Rather, doctors want to test study drugs to see which one works best to stop breast cancer cells from dividing and growing. This study will be done within a short “window” of time, starting soon after breast cancer is diagnosed and ending at the time of breast surgery.
In this window-of-opportunity study, we want to test which of the study drugs works best to stop breast cancer cells from dividing and growing. To do this, we will measure Ki-67 levels in a sample from the biopsy taken to diagnose your breast cancer. Ki-67 will then be measured again in a sample from your breast surgery after you have finished the study treatment.
The study treatment consists of giredestrant alone, giredestrant with triptorelin, or anastrozole with triptorelin.
The study treatment will be given for about 1 month.
Patient Profile
Premenopausal patients with histologically confirmed ER-positive/HER2-negative untreated invasive breast cancer, stage I, stage II or operable stage III (T4 excluded), with available tumor tissue and Ki-67 ≥10% in diagnostic biopsy.
Where’s this trial being run?
Cork University Hospital, St James’s Hospital, and University Hospital Galway
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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QuestionsSummary Data
| Name: | PREcoopERA |
|---|---|
| Number: | 23-13 |
| Full Title: | A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer (PREcoopERA) |
| Principal Investigator: | Prof Roisin Connolly (CUH), Dr Ciara O'Hanlon Brown (SJH), Prof Maccon Keane (UHG) |
|---|---|
| Type: | Collaborative |
| Sponsor: | ETOP-IBCSG |
| Recruitment Started: |
Global: 23-Jan-2024 Ireland: 22-Oct-2024 |
| Global Recruitment Target: | 220 |
|---|---|
| Ireland Recruitment Target: | 15 |