OncoMatch/Clinical Trials/NCT05601700
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
Is NCT05601700 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Letrozole tablets and carboplatin AUC 5 and paclitaxel 175 mg/m2 for carcinoma, ovarian epithelial.
Treatment: Letrozole tablets · carboplatin AUC 5 and paclitaxel 175 mg/m2 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Required: ESR1 immunohistochemically determined positivity (≥ 10%) for ER expression (≥ 10%)
Immunohistochemically determined positivity (≥ 10%) for ER and/or PgR expression
Required: PR (PGR) immunohistochemically determined positivity (≥ 10%) for PgR expression (≥ 10%)
Immunohistochemically determined positivity (≥ 10%) for ER and/or PgR expression
Disease stage
Required: Stage III, IV
Grade: 1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — upfront
Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status.
Cannot have received: neoadjuvant chemotherapy
Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease
Cannot have received: radiotherapy
Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease
Cannot have received: hormonal therapy
Previous hormonal therapy for the treatment of this disease
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 10.0 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3.0 x ULN; Alkaline phosphatase ≤ 2.5 x ULN; Albumin ≥ 2.8 g/dL
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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