Actively Recruiting
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
Led by Ente Ospedaliero Ospedali Galliera · Updated on 2025-01-27
132
Participants Needed
19
Research Sites
365 weeks
Total Duration
On this page
Sponsors
E
Ente Ospedaliero Ospedali Galliera
Lead Sponsor
I
Istituto Di Ricerche Farmacologiche Mario Negri
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Newly diagnosed low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum confirmed by central pathology
- Estrogen and/or progesterone receptor positive (at least 10%) confirmed centrally
- Underwent upfront surgery with maximal cytoreduction, with optimal or suboptimal residual disease
- Stage III-IV disease according to 2018 FIGO classification with recent imaging and physical exam
- Postmenopausal status defined by surgery, amenorrhea, age, and hormone levels as specified
- Randomization within 60 days of primary cytoreductive surgery
- ECOG performance status 0-1
- Ability to take oral medications
- Adequate bone marrow, liver, and kidney function per specified laboratory values
- Provided written informed consent before any study procedures
You will not qualify if you...
- Other cancers within the last 5 years except treated non-melanoma skin cancer
- Prior neoadjuvant chemotherapy or radiotherapy for this disease
- Previous hormonal therapy for this disease
- Known allergies to letrozole, carboplatin, or paclitaxel
- Active or uncontrolled infections
- Brain metastases
- Severe cardiac disease within 6 months before randomization
- NYHA Class III or worse heart failure
- Neuropathy grade 2 or higher
- Untreated spine or femur fractures
- Untreated osteoporosis with T-score -2.5 or lower
- Use of certain medications that affect letrozole levels
- Severe medical problems limiting study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 19 locations
1
Ospedale San Donato
Arezzo, AR, Italy, 52100
Actively Recruiting
2
Ospedale degli Infermi
Ponderano, BI, Italy, 13875
Actively Recruiting
3
Ospedale San Martino
Belluno, BL, Italy, 32100
Actively Recruiting
4
Fondazione Poliambulanza
Brescia, BS, Italy, 25124
Actively Recruiting
5
ASST degli Spedali Civili di Brescia
Brescia, BS, Italy
Actively Recruiting
6
Ospedale Sant'Anna
Como, CO, Italy, 22042
Actively Recruiting
7
IRST
Meldola, FC, Italy, 47014
Actively Recruiting
8
AOU Ferrara
Ferrara, FE, Italy, 44124
Actively Recruiting
9
Medical Oncology Division, Ente Ospedaliero Ospedali Galliera
Genova, Genova, Italy, 16128
Actively Recruiting
10
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy, 20133
Actively Recruiting
11
IEO
Milan, MI, Italy, 20141
Actively Recruiting
12
IRCCS Istituto Oncologico Veneto
Padua, PD, Italy, 35128
Actively Recruiting
13
IFO Regina Elena
Roma, RM, Italy, 00144
Actively Recruiting
14
Policlinico Umberto I
Roma, RM, Italy, 00161
Actively Recruiting
15
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy, 00168
Actively Recruiting
16
IRCCS Istituto Oncologico Veneto
Castelfranco Veneto, TV, Italy, 31033
Actively Recruiting
17
Ospedale Ca' Foncello
Treviso, TV, Italy, 31100
Actively Recruiting
18
Ospedale Del Ponte
Varese, VA, Italy, 21100
Actively Recruiting
19
AUSL Romagna
Rimini, Italy
Actively Recruiting
Research Team
A
Andrea DeCensi, Prof.
CONTACT
M
Marianna Fava, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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