Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEnte Ospedaliero Ospedali Galliera
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Patients who underwent bilateral salpingo-oophorectomy;
Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months and age ≥60 years;
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Letrozole tablets
DrugATC: L02BG04
carboplatin AUC 5 and paclitaxel 175 mg/m2
DrugATC: L01XA02 and ATC: L01CD01 respectively
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Experimental armExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
the time from the date of randomization to the date of local or regional relapse, distant metastasis, or death from any cause, whichever comes first. Patients not recurred, not progressed or not died while on study or patients lost to f-up will be censored at their last disease assessment date.
Time frame
54 months up to 84 monthsSecondary outcomes
1
Objective Response Rate (ORR)
the percentage of patients with an objective response, i.e. patients who will experience a complete response (CR), or a partial response (PR) as determined by RECIST 1.1. Each patient will be assigned the best response ever recorded during the trial.
Time frame
54 months up to 84 months2
Predictive effect of ER and PgR (% expression) on response to letrozole in terms of PFS and ORR
the time from the date of randomization to the date of local or regional relapse, distant metastasis, or death from any cause, whichever comes first according to ER and PgR % expression.
Time frame
54 months up to 84 months3
Clinical Benefit (CB)
the percentage of patients who will experience a CR or PR or stable disease (SD). Each patient will be assigned the best response ever recorded during the trial.
Time frame
54 months up to 84 months4
Overall survival (OS)
the time from the date of randomization to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive.
Time frame
54 months up to 84 monthsOther outcomes
1
Translational Objective 1
mutational and gene expression profile of the disease by means of NGS based methodology on tissue
Time frame
54 months up to 84 months2
Translational Objective 2
PFS, OS and ORR according to androgen receptor (AR) expression
Time frame
54 months up to 84 months3
Translational Objective 3
PFS, OS and ORR according to circulating tumor DNA (ctDNA) on liquid biopsies
Time frame
54 months up to 84 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ente Ospedaliero Ospedali Galliera
Lead sponsor
Istituto Di Ricerche Farmacologiche Mario Negri
Collaborator
Humanitas Hospital, Italy
Collaborator
Source ClinicalTrials.gov