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

• Status: Not yet recruiting
• Trial end date: 2030-07-09
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Letrozole

Criteria

Inclusion Criteria:

1. Older than 18 years old;

2. Initial diagnosed with stage I-IV(FIGO2009) endometrial epithelial cancer, regardless of pathological types;

3. 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;

4. Life expectancy of 2 or more years.

5. Confirmed NSMP with intermediate or higher prognostic risk according to post-operative clinical pathological assessment and molecular classification;

1. 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

2. 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

3. High prognostic risk group:

• Stage Ill-IVA with no residual disease

• Stage I-IVA non-endometrioid (serous, clear cell, undifferentiated carcinoma, carcinosarcoma, mixed) with myometrial invasion, and with no residual disease

4. Advanced Metastatic:

• Stage III-IVA with residual disease

• Stage IVB Low grade: G1-2; High grade:G3;

6. Received conventional adjuvant therapy after surgery according to the latest version of NCCN or ESGO/ESTRO/ESP guidelines;

7. Patients with residual tumor after surgery (any single site) must have achieved complete response or partial response after post-operative adjuvant therapy;

8. Expected start of letrozole maintenance within 3 months after adjuvant therapy;

9. Adequate organ function as defined by the following criteria:

• White blood cell (WBC) ≥ 3000/μL or Absolute neutrophil count (ANC) ≥1500/μL

• Platelets ≥100,000/μL

• Serum Aspartate transaminase (AST) and/or serum alanine transaminase (ALT) ≤ 2 times upper limit of normal (ULN)

• Serum creatinine ≤2 times ULN

10. Karnofsky score ≥60;

11. Eastern Cooperative Oncology Group (ECOG) Performance status ≤2;

12. Ability to take anti-thyroid drugs, calcium, vitamin D or bisphosphonates together.

Exclusion Criteria:

1. Endometrial stromal tumor;

2. Recurrent endometrial cancers;

3. Patients with low prognostic risk according to post-operative clinical pathological assessment ( Stage IA endometrioid + low-grade* +LVSI negative or focal);

4. Patients require no adjuvant therapy after surgery;

5. Negative expression in estrogen receptor or progesterone receptor according to post-operative Immunohistochemistry;

6. Received other adjuvant therapy within 6 months before surgery: including neoadjuvant therapy, hormone therapy, targeted therapy, immunotherapy and biotherapy, etc;

7. Patients with contraindications for letrozole;

8. Patients with other malignant tumors;

9. History of vital organ transplantation;

10. History of immune disease and need to take immunosuppressor;

11. Uncontrolled psychiatric illness or other situations that would limit compliance with study requirements;

12. History of drug abuse;

13. Participated in other clinical trials;

14. No ability or intention to receive letrozole maintenance/sign the consent/obey the study requirements.