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A Randomized Phase II Trial of Everolimus and Letrozole or Hormonal Therapy (Tamoxifen/Medroxyprogesterone Acetate) in Women With Advanced, Recurrent, or Persistent Endometria Carcinoma
The main purpose of this study is to evaluate the effectiveness of the combination of the drugs Everolimus and Letrozole compared to Tamoxifen and Medroxyprogesterone acetate in treating endometrial cancer and to determine the types and severity of side effects caused by treatment with these drug combinations.
Details
| Lead sponsor | GOG Foundation |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 74 |
| Start date | 2015-05-21 |
| Completion | 2024-08-22 |
Conditions
- Advanced, Persistent, or Recurrent Endometrial Cancer
Interventions
- Everolimus
- Tamoxifen
- Letrozole
- Medroxyprogesterone Acetate
Primary outcomes
- Frequency of Response — From date of randomization until the date of first documented progression or date of death , up to 3 years.
A confirmed complete or partial response as defined by RECIST 1.1 was considered a response. "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Countries
United States