Phase III trial on hormonal therapy versus standard chemotherapy for Estrogen/Progesterone Receptor positive low-grade serous Epithelial ovarian cancer.

Letrozole for Estrogen/Progesterone Receptor positive low-grade serous Epithelial ovarian cancer. A randomized phase III trial. LEPRE Trial - LEPRE Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003066-39-IT

Enrollment

130

Registered

2022-01-26

Start date

2022-02-21

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a low-grade serous epithelial carcinoma of the ovary (LGSCO) including cancer of fallopian tube and peritoneum, FIGO III-IV stage and with ER+ and/or PgR+ after primary surgery are eligible. MedDRA version: 21.1 Level: PT Classification code 10070907 Term: Ovarian cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10070908 Term: Ovarian cancer stage IV System Organ

Interventions

Trade Name: LETRIX - 2.5 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER AL/PVDC/PVC/PE/PVDC Product Name: Letrix Product Code: [Letrix] Pharmaceutical Form: Tablet INN or Proposed INN: LETROZ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years. 2. Newly diagnosed, low-grade serous carcinoma of the ovary including cancer of fallopian tube and peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma). This is to be confirmed by a central pathology review performed at the Coordinating Centre. 3. Immunohistochemically determined positivity (= 10%) for PgR and/or ER expression. This is to be confirmed by centralized review. 4. Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status. 5. Stage III-IV according to 2018 FIGO classification. 6. Postmenopausal status (>12 consecutive months without menstruation) or patients who have undergone a bilateral salpingo-oophorectomy. 7. Randomization must take place within 60 days of primary cytoreductive surgery. 8. Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-1. 9. To be able to take oral medications. 10. 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. 11. Written informed consent obtained prior to any study-specific procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. Other malignancy within the last 5 years, except for non-melanoma skin cancer adequately treated. 2. Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease. 3. Previous hormonal therapy for the treatment of this disease. 4. Known hypersensitivity to letrozole or known hypersensitivity/intolerance to carboplatin/paclitaxel therapy. 5. Active or uncontrolled systemic infection. 6. Known central nervous system metastases. 7. Severe cardiac disease, such as myocardial infarction or unstable angina within 6 months prior to randomization. 8. New York Heart Association (NYHA) Class III or greater congestive heart failure. 9. Neuropathy grade 2 or higher. 10. History of fractures of the spine or femur not properly treated. 11. Known osteoporosis (T score of -2.5 or lower) not adequately treated with bisphosphonates or RANKL inhibitors (A dual-energy x-ray absorptiometry (DEXA) of the femoral neck is recommended). 12. Concurrent severe medical problems or any condition that would significantly limit full compliance with the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to determine if letrozole is superior to standard chemotherapy in terms of progression-free survival (PFS) in patients with advanced low-grade serous epithelial ovarian carcinoma positive for estrogen and/or progesterone receptors.;Secondary Objective: •to evaluate the response of tumor to letrozole compared with standard chemotherapy in terms of objective response rate (ORR); •To test the predictive effect of ER, PgR on response to letrozole in terms of PFS and ORR; •to evaluate the possible negative association between the effect of letrozole, in terms of PFS and ORR, and the proliferative index Ki67; •to evaluate the impact of letrozole compared with the impact of standard chemotherapy on patients’ health related quality of life evaluated by MENQOL; •to evaluate the impact of letrozole compared with standard chemotherapy on patients’ musculoskeletal pain evaluated by BPI-SF; •to describe the OS according to randomization arm. •to evaluate the safety of letrozole compared with standard chemotherapy.;Primary end point(s): The primary endpoint is PFS, defined for each patient as 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.;Timepoint(s) of evaluation of this end point: Tumor assessments should be performed by radiological assessment and CA-125 every 6 months until PD.	—

Measure

Time frame

Main Objective: The primary objective is to determine if letrozole is superior to standard chemotherapy in terms of progression-free survival (PFS) in patients with advanced low-grade serous epithelial ovarian carcinoma positive for estrogen and/or progesterone receptors.;Secondary Objective: •to evaluate the response of tumor to letrozole compared with standard chemotherapy in terms of objective response rate (ORR); •To test the predictive effect of ER, PgR on response to letrozole in terms of PFS and ORR; •to evaluate the possible negative association between the effect of letrozole, in terms of PFS and ORR, and the proliferative index Ki67; •to evaluate the impact of letrozole compared with the impact of standard chemotherapy on patients’ health related quality of life evaluated by MENQOL; •to evaluate the impact of letrozole compared with standard chemotherapy on patients’ musculoskeletal pain evaluated by BPI-SF; •to describe the OS according to randomization arm. •to evaluate the safety of letrozole compared with standard chemotherapy.;Primary end point(s): The primary endpoint is PFS, defined for each patient as 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.;Timepoint(s) of evaluation of this end point: Tumor assessments should be performed by radiological assessment and CA-125 every 6 months until PD.

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Secondary

Measure	Time frame
Secondary end point(s): Objective Response Rate (ORR), defined as the percentage of patients with an objective response determined by a complete response (CR) or a partial response (PR) as determined by RECIST 1.1.; Clinical Benefit (CB), defined as the percentage of patients who will experience a CR or PR or stable disease (SD).; OS, defined for each patient as the time from the date of randomization to the date of death from any cause.; Health-related QoL assessed by the Menopause Quality of Life questionnaire (MENQOL) questionnaire.; Musculoskeletal Pain assessed by BPI-SF questionnaire.;Timepoint(s) of evaluation of this end point: Tumor assessments should be performed by radiological assessment and CA-125 every 6 months until PD.; Tumor assessments should be performed by radiological assessment and CA-125 every 6 months until PD.; Tumor assessments should be performed by radiological assessment and CA-125 every 6 months until PD.; The evaluation will be performed at visit at 3 months and at disease progression (Both arms).; The evaluation will be performed at visit at 3 months and at disease progression (Both arms).	—

Measure

Time frame

Secondary end point(s): Objective Response Rate (ORR), defined as the percentage of patients with an objective response determined by a complete response (CR) or a partial response (PR) as determined by RECIST 1.1.; Clinical Benefit (CB), defined as the percentage of patients who will experience a CR or PR or stable disease (SD).; OS, defined for each patient as the time from the date of randomization to the date of death from any cause.; Health-related QoL assessed by the Menopause Quality of Life questionnaire (MENQOL) questionnaire.; Musculoskeletal Pain assessed by BPI-SF questionnaire.;Timepoint(s) of evaluation of this end point: Tumor assessments should be performed by radiological assessment and CA-125 every 6 months until PD.; Tumor assessments should be performed by radiological assessment and CA-125 every 6 months until PD.; Tumor assessments should be performed by radiological assessment and CA-125 every 6 months until PD.; The evaluation will be performed at visit at 3 months and at disease progression (Both arms).; The evaluation will be performed at visit at 3 months and at disease progression (Both arms).

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Countries

Italy

Contacts

Public ContactTraslational Research in Gynecology

Istituto di Ricerche Farmacologiche Mario Negri IRCCS

lepre@marionegri.it0233200231

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026