PREcoopERA Window-of-Opportunity trial of giredestrant+/- triptorelin vs. anastrozole+triptorelin in premenopausal patients with ER-positive/HER2-negative early breast cancer

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Background: Current standard care for premenopausal women with estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer frequently involves ovarian function suppression (OFS) alongside tamoxifen or aromatase inhibitor therapy. However, younger patients may exhibit lower treatment compliance due to OFS toxicity, which often affects their quality of life. While luteinizing hormone releasing hormone (LHRH) agonists are effective as OFS, their monthly injections and side-effects may be unacceptable to some patients. Giredestrant a new oral selective ER degrader (SERD) exhibits promise as a potent anti-proliferative agent. PREcoopERA is a biomarker-driven window-of-opportunity (WOO) study, lasting four weeks prior to surgery, seeking to assess giredestrant's anti-proliferative efficacy with and without OFS in premenopausal patients with ER-positive/HER2-negative operable invasive breast cancer. Trial Design: In this multicenter, open-label, 2:2:1 randomized WOO trial, 220 premenopausal patients with ER-positive/HER2-negative operable invasive breast cancer will be randomly assigned to receive either giredestrant alone, giredestrant plus triptorelin, or anastrozole plus triptorelin. Patients with metastatic or inflammatory breast cancer as well as specific chronic conditions are excluded from this trial. Primary endpoint (EP) is the change in Ki-67 between pre- and post-treatment tumor biopsies. Secondary EPs include complete cell cycle arrest (Ki-67≤2.7% on post-treatment tumor tissue) and safety. The first patient was enrolled in Jan 2024.

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