Phase II study of everolimus and letrozole in patients with recurrent endometrial carcinoma
Phase 2N = 38
- Population
- Women with recurrent endometrial carcinoma considered incurable, with measurable disease (38 enrolled, 35 evaluable for response)
- Design
- Two-institution phase II trial. Everolimus 10 mg and letrozole 2.5 mg orally daily in 4-week cycles until progression, toxicity or complete response. Patients had measurable disease and up to two prior cytotoxic regimens. 38 enrolled, 35 evaluable for response.
- Primary endpoint
- CBR
- Arms
- Everolimus plus letrozole (single arm) (experimental, n = 38): Everolimus 10 mg and letrozole 2.5 mg orally daily
- People
- Slomovitz BM
Show the numbers
| Endpoint | Analysis | Everolimus plus letrozole (single arm) | Control | Effect |
|---|---|---|---|---|
| CBR35 patients evaluable for responseComplete response, partial response or stable disease for at least 16 weeks by RECIST 1.0 | primarySlomovitz 2015 | 40% | — | 14 of 35 patients. |
| ORR35 patients evaluable for response | primarySlomovitz 2015 | 32% | — | 11 of 35 patients: nine complete and two partial responses. Serous histology was the best predictor of lack of response. |
| Endpoint | Analysis | Everolimus plus letrozole (single arm) | Control | Effect |
|---|---|---|---|---|
| CBR35 patients evaluable for responseComplete response, partial response or stable disease for at least 16 weeks by RECIST 1.0 | primarySlomovitz 2015 | 40% | — | 14 of 35 patients. |
| ORR35 patients evaluable for response | primarySlomovitz 2015 | 32% | — | 11 of 35 patients: nine complete and two partial responses. Serous histology was the best predictor of lack of response. |