Letrozole for hormone receptor-positive low-grade ovarian cancer: Preliminary toxicity results of a phase III trial.
Alessio Carbone, Elena Biagioli, Vanda Salutari...
https://pubmed.ncbi.nlm.nih.gov/41392465Actively Recruiting
Phase 3
Age: 18Years +
FEMALE
ID05601700
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer: a Randomized Phase III Trial (LEPRE Trial)
Led by Ente Ospedaliero Ospedali Galliera · Updated on 2025-01-27
132
Participants Needed
19
Research Sites
N/A
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
Researchers are evaluating whether letrozole is more effective than standard chemotherapy for treating patients with hormone receptor positive low-grade serous epithelial ovarian carcinoma (LGSCO). This phase III, open-label, randomized trial aims to see if letrozole can extend progression-free survival compared to carboplatin and paclitaxel chemotherapy. The study also explores tumor response, quality of life, pain, overall survival, safety, and genetic markers related to the disease. Participants will be randomly assigned to one of two groups: one group takes letrozole tablets daily by mouth for up to 60 months or until disease progression, while the other group receives carboplatin and paclitaxel intravenously on day 1 every 21 days for 6 to 8 cycles. The treatments are compared directly to assess their effects on cancer control and patient well-being. During the study, participants will have regular assessments including tumor response evaluations, quality of life questionnaires, pain inventory, and safety monitoring according to standard criteria. Genetic profiling and circulating tumor DNA will be analyzed to understand disease characteristics. Progression-free survival will be tracked for up to 84 months, with ongoing monitoring of overall survival and adverse events. Participants will be followed closely to observe treatment effects and side effects throughout the trial period.
CONDITIONS
Brief Title
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Newly diagnosed low-grade serous carcinoma of ovary, fallopian tube, or peritoneum confirmed by central pathology review
- Estrogen receptor (ER) and/or progesterone receptor (PgR) expression of 10% or higher by centralized review
- Underwent upfront surgery with maximal tumor removal
- Stage III-IV disease based on 2018 FIGO classification, confirmed by recent imaging and examination
- Postmenopausal status defined by surgery or amenorrhea criteria
- Randomization within 60 days of primary surgery
- ECOG performance status 0-1
- Ability to take oral medications
- Adequate bone marrow, liver, and kidney function as specified
- Provided written informed consent
You will not qualify if you...
- Other cancers within last 5 years except treated non-melanoma skin cancer
- Prior neoadjuvant chemotherapy or radiotherapy for this disease
- Previous hormonal therapy for this disease
- Known allergy or intolerance to letrozole, carboplatin, or paclitaxel
- Active or uncontrolled systemic infection
- Known brain metastases
- Severe heart disease including recent heart attack or unstable angina
- Congestive heart failure NYHA Class III or higher
- Moderate or severe neuropathy (grade 2 or above)
- Untreated fractures of spine or femur
- Untreated severe osteoporosis
- Use of medications that interfere with letrozole metabolism
- Other serious medical conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 60 months for letrozole or approximately 18 to 24 weeks for chemotherapy
Participants receive either letrozole tablets daily until disease progression or up to 60 months, or receive carboplatin and paclitaxel chemotherapy intravenously every 21 days for 6 to 8 cycles.
Day 1 visits every 21 days for 6 to 8 cycles for chemotherapy; daily oral administration for letrozole
Follow-up
Duration - Up to 84 months
Participants are monitored for progression-free survival, overall survival, response rates, and safety after treatment ends.
Periodic visits as scheduled for monitoring
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
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Research Team
A
Andrea DeCensi, Prof.
M
Marianna Fava, PhD
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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