A phase II, multicenter, open-label study of abemaciclib and letrozole in patients with estrogen receptor-positive rare ovarian cancer: ALEPRO trial. - 2024
[en] [en] BACKGROUND: Low-grade serous and endometrioid ovarian cancers and adult-type granulosa cell tumors are rare ovarian malignancies that show high estrogen receptor positivity. Recurrences of these subtypes of ovarian cancer are often treated with conventional chemotherapy, although response rates are disappointing.
PRIMARY OBJECTIVE: To determine the overall response rate of the combination therapy of abemaciclib and letrozole in patients with estrogen receptor-positive rare ovarian cancers.
STUDY HYPOTHESIS: The combination therapy of abemaciclib and letrozole will provide a clinically meaningful therapeutic benefit, with an overall response rate of >25%.
TRIAL DESIGN: This is a phase II, international, multicenter, open-label, single-arm study to evaluate the efficacy and safety of abemaciclib and letrozole in patients with advanced, recurrent, and/or metastatic estrogen receptor-positive, rare ovarian cancer. The study will follow a tandem two-stage design.
MAJOR INCLUSION/EXCLUSION CRITERIA: Patients must have histologically confirmed low-grade serous/endometrioid ovarian cancer or adult-type granulosa cell tumor with estrogen receptor positivity on immunohistochemistry. Patients need to have recurrent and measurable disease according to Radiologic Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A maximum of two prior lines of endocrine therapy are allowed, and patients cannot have previously received a cyclin-dependent kinase inhibitor. Patients with platinum-refractory disease are not allowed in any stage of the study.
PRIMARY ENDPOINT: Investigator-assessed confirmed overall response rate, defined as the proportion of patients with a complete or partial response according to RECIST v1.1.
SAMPLE SIZE: 40 to 100 patients will be included, depending on the results of the interim analysis. Patients will be included in Belgium, France and the Netherlands.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Patient recruitment will be completed by the end of 2025 and reporting of the final study results will be done by the end of 2027.
TRIAL REGISTRATION NUMBER: NCT05872204.
Disciplines :
Oncology
Author, co-author :
Ottenbourgs, Tine ; Gynaecological Oncology Laboratory, KU Leuven, Leuven, Belgium
van Gorp, Toon ; Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium
Kridelka, Frédéric ; Université de Liège - ULiège > Département des sciences cliniques > Gynécologie-Obstétrique
Baert, Thaïs; Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium
Denys, Hannelore; Department of Medical Oncology, University Hospital Ghent, Ghent, Belgium
Selle, Frédéric; Department of Medical Oncology, Groupe hospitalier Diaconesses Croix Saint-Simon, Paris, France
Baas, Inge; Department of Medical Oncology, University Medical Centre Utrecht, Utrecht, Netherlands
Van Rompuy, Anne-Sophie; Department of Pathology, University Hospitals Leuven, Leuven, Belgium
Eli Lilly and Company will provide the study drug abemaciclib for this clinical trial. This research is funded by Kom Op Tegen Kanker (Stand Up To Cancer), the Flemish cancer society.
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