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Letrozole for Estrogen/Progesterone Receptor positive low-grade serous Epithelial ovarian cancer. A randomized phase III trial. LEPRE Trial
EU CTIS ID: 2024-516874-31-00
What this study is testing
The primary objective is to determine if letrozole is superior to standard chemotherapy in terms of progression-free survival (PFS) in patients with advanced low-grade serous epithelial ovarian carcinoma positive for estrogen and/or progesterone receptors.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 18 years. 2. Newly diagnosed, low-grade serous carcinoma of the ovary including cancer of fallopian tube and peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma). This is to be confirmed via nuclear p53 immunohistochemistry testing by a central pathology review performed at the Coordinating Centre. 3. Immunohistochemically determined positivity (≥ 10%) for PgR and/or ER expression. This is to be confirmed by centralized review. 4. Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status. 5. Stage III-IV according to 2018 FIGO classification. Furthermore, for a proper baseline evaluation patients must have undergone contrast-enhanced CT-scan of the chest, abdomen and pelvis within 28 days prior to randomization. If CT-scan is not recommended (e.g. for allergy to contrast agent) MRI or 18F-FDG PET/CT-scan are allowed. The imaging evaluation must be accompanied by an anamnestic and physical examination within 14 days prior to randomization. 6. Postmenopausal, defined as any of the following criteria: - Patients who underwent bilateral salpingo-oophorectomy; - Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months and age ≥60 years; - Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months, age <60 years and plus FSH and serum estradiol levels within the laboratory’s reference ranges for postmenopausal women. 7. Randomization must take place within 90 days (preferably within 60 days) of primary cytoreductive surgery. 8. Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-1. 9. To be able to take oral medications 10. Adequate bone marrow, hepatic and renal functions as defined below: - Absolute neutrophil count (ANC) ≥ 1500/mm3 - Platelets ≥ 100,000/mm3 - Hemoglobin ≥ 10.0 g/dL - Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) - ALT and AST ≤ 3.0 x ULN - Alkaline phosphatase ≤ 2.5 x ULN - Albumin ≥ 2.8 g/dL - Serum creatinine ≤ 1.5 x ULN. 11. Written informed consent obtained prior to any study-specific procedure.
You likely can't join if
- 1. Other malignancy within the last 5 years, except for non-melanoma skin cancer adequately treated. 2. Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease. 3. Previous hormonal therapy for the treatment of this disease. 4. Known hypersensitivity to letrozole or known hypersensitivity/intolerance to carboplatin/paclitaxel therapy. 5. Active or uncontrolled systemic infection. 6. Known central nervous system metastases. 7. Severe cardiac disease, such as myocardial infarction or unstable angina within 6 months prior to randomization. 8. New York Heart Association (NYHA) Class III or greater congestive heart failure. 9. Neuropathy grade 2 or higher. 10. History of fractures of the spine or femur not properly treated. 11. Known osteoporosis (dual-energy x-ray absorptiometry (DEXA) of the femoral neck T score of −2.5 or lower) not adequately treated with bisphosphonates or RANKL inhibitors. 12. Concomitant use of inducers of CYP3A4 (e.g. phenytoin, rifampicin, carbamazepine, phenobarbital, and St. John’s Wort) which may reduce exposure to letrozole. Concomitant use of medicinal products with a narrow therapeutic index that are substrates for CYP2C19 (e.g. phenytoin, clopidrogel) that may have their systemic serum concentrations altered by letrozole. 13. Concurrent severe medical problems or any condition that would significantly limit full compliance with the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.