OncoMatch/Clinical Trials/NCT05601700
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
Is NCT05601700 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05601700 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior neoadjuvant chemotherapy, radiotherapy, hormonal therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 immunohistochemically determined positivity (≥ 10%) for ER expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR immunohistochemically determined positivity (≥ 10%) for PgR expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages