Letrozole as Maintenance Therapy for Post-surgical Endometrial Cancer Patients With NSMP

NCT05454358 | Terminated Phase 2

• 1 other identifier: 2022-54
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Aim to investigate the effect of Letrozole as maintenance after adjuvant treatment on the prognosis of post-operative endometrial cancer patients with non-specific molecular profile.

Conditions

Endometrial Cancer

Keywords

endometrial cancer; letrozole; maintenance therapy; molecular classification; non-specific molecular profile

Outcome Measures

Primary Outcomes (1)

• the 3-year Progression-Free-Survival(PFS)

  The percentage of patients who have first relapse within 3 years after surgery

  3 years

Secondary Outcomes (5)

• the 3-year Overall survival(OS)

  3 years

• the 5-year PFS and OS

  5 years

• Incidence of adverse events

  From date of recruitment, assessed up to 5 years

• Quality of life change

  baseline, 1 year, and 2 years

• Site of recurrence

  8 years

Other Outcomes (1)

• Recurrence related factors

  8 years

Study Arms (2)

Letrozole

EXPERIMENTAL

Letrozole 0.5mg qd po for 2 years after postoperative adjuvant therapy

Drug: Letrozole 2.5mg

Observation

NO INTERVENTION

Observation alone without any other therapy after postoperative adjuvant therapy

Interventions

Letrozole 2.5mg DRUG

Letrozole 0.5mg qd po for 2 years after postoperative adjuvant therapy

Also known as: Letrozole 2.5mg qd po for 2 years

Letrozole

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years old;
• Initial diagnosed with stage I-IV(FIGO2009) endometrial epithelial cancer, regardless of pathological types;
• Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy and sentinel node biopsy; pelvic lymph node sampling and para-aortic lymph node sampling are optional;
• Life expectancy of 2 or more years.
• Confirmed NSMP with intermediate or higher prognostic risk according to post-operative clinical pathological assessment and molecular classification;
• Intermediate prognostic risk group:
• Stage lB endometrioid + Iow-grade\* + LVSI negative or focal
• Stage IA endometrioid + high-grade\*+ LVSI negative or focal
• Stage IA non-endometrioid (serous, clear cell, undifferentiated carcinoma, carcinosarcoma, mixed) without myometrial invasion
• High-intermediate prognostic risk group:
• Stage I endometrioid + substantial LVSI, regardless of grade and depth of invasion
• Stage lB endometrioid high-grade\*, regardless of LVSI status
• Stage II
• High prognostic risk group:
• Stage Ill-IVA with no residual disease

You may not qualify if:

• Endometrial stromal tumor;
• Recurrent endometrial cancers;
• Patients with low prognostic risk according to post-operative clinical pathological assessment ( Stage IA endometrioid + low-grade\* +LVSI negative or focal);
• Patients require no adjuvant therapy after surgery;
• Negative expression in estrogen receptor or progesterone receptor according to post-operative Immunohistochemistry;
• Received other adjuvant therapy within 6 months before surgery: including neoadjuvant therapy, hormone therapy, targeted therapy, immunotherapy and biotherapy, etc;
• Patients with contraindications for letrozole;
• Patients with other malignant tumors;
• History of vital organ transplantation;
• History of immune disease and need to take immunosuppressor;
• Uncontrolled psychiatric illness or other situations that would limit compliance with study requirements;
• History of drug abuse;
• Participated in other clinical trials;
• No ability or intention to receive letrozole maintenance/sign the consent/obey the study requirements.

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: collaborator
• Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiaojun Chen, Ph.D, M.D

  Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Obstetrics and Gynecology Hospital of Fudan University

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 12, 2022
• Study Start: August 2, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (1)