GnRHa + Letrozole vs Diane-35 + Metformin in Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients

• Status: Not yet recruiting
• Trial end date: 2025-03-30
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.

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

Details

• Lead Sponsor: Xiaojun Chen
• Treatments: Cyproterone; Cyproterone acetate, ethinyl estradiol drug combination; Ethinyl Estradiol; Letrozole

Criteria

Inclusion Criteria:

• Have a confirmed initial pathological diagnosis based upon hysteroscopy:

histologically prove EAH or well-differentiated EEC G1 without myometrial invasion

• No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound

• Using progestin, any of the following therapy, as first-line treatment:

1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not

2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not

3. LNG-IUS inserted

• Progestin-insensitive:

1. remained with stable disease after 7 months of progestin use

2. did not achieve CR after 10 months of progestin use

• Have a desire for remaining reproductive function or uterus

• Good compliance with adjunctive treatment and follow-up

Exclusion Criteria:

• Combined with severe medical disease or severely impaired liver and kidney function

• Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis

• Patients with other types of endometrial cancer or other malignant tumors of the reproductive system

• Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with Diane-35, GnRHa, Letrozole or MET

• Strong request for uterine removal or other conservative treatment

• Known or suspected pregnancy

• Acute severe disease such as stroke or heart infarction or a history of thrombosis disease

• Smoker(>15 cigarettes a day)