AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)

RecruitingPhase 3Ages 18 Years - anyFemaleEnte Ospedaliero Ospedali Galliera
💬

In plain words

What the trial is, and whether it could suit you

This is an Italian, multicenter, randomized, open-label phase III trial which will evaluate if Letrozole is superior to standard adjuvant chemotherapy in patients with hormone receptor positive low-grade serous epithelial carcinoma of the ovary (LGSCO). The hypothesis is that letrozole will significantly prolong median progression free survival (PFS) compared with the standard chemotherapy treatment, namely carboplatin AUC 5 and paclitaxel 175 mg/m2.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: I - 1. Age ≥ 18 years. I - 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. I - 3. Immunohistochemically determined positivity (≥ 10%) for ER and/or PgR expression. This is to be confirmed by centralized review. I - 4. Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status. I - 5. Stage III-IV according to 2018 FIGO classification. For proper staging: * 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. I - 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 FSH and serum estradiol levels within the laboratory's reference ranges for post-menopausal women. I - 7. Randomization must take place within 60 days of primary cytoreductive surgery. I - 8. Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-1. I - 9. To be able to take oral medications. I - 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. I - 11. Written informed consent obtained prior to any study-specific procedure. Exclusion Criteria: E - 1. Other malignancy within the last 5 years, except for non-melanoma skin cancer adequately treated. E - 2. Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease. E - 3. Previous hormonal therapy for the treatment of this disease. E - 4. Known hypersensitivity to letrozole or known hypersensitivity/intolerance to carboplatin/paclitaxel therapy. E - 5. Active or uncontrolled systemic infection. E - 6. Known central nervous system metastases. E - 7. Severe cardiac disease, such as myocardial infarction or unstable angina within 6 months prior to randomization. E - 8. New York Heart Association (NYHA) Class III or greater congestive heart failure. E - 9. Neuropathy grade 2 or higher. E - 10. History of fractures of the spine or femur not properly treated. E - 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. E - 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. E - 13. Concurrent severe medical problems or any condition that would significantly limit full compliance with the study.
💊

What it tests

  • Letrozole tablets
  • carboplatin AUC 5 and paclitaxel 175 mg/m2
📍

Where

19 sites
Ospedale San Donato
Arezzo, Italy
Ospedale degli Infermi
Ponderano, Italy
Ospedale San Martino
Belluno, Italy
Fondazione Poliambulanza
Brescia, Italy
ASST degli Spedali Civili di Brescia
Brescia, Italy
Ospedale Sant'Anna
Como, Italy
IRST
Meldola, Italy
AOU Ferrara
Ferrara, Italy

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy