Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer

Summary

This phase II trial studies how well ribociclib and letrozole work in treating patients with estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has returned (come back) after a period of improvement. Ribociclib may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Cancer cells that are estrogen receptor positive may need estrogen to grow. Letrozole lowers the amount of estrogen made by the body and this may stop the growth of tumor cells that need estrogen to grow. Giving ribociclib together with letrozole may be an effective treatment in patients with ovarian, fallopian tube, primary peritoneal, or endometrial cancer.

Timeline

Start

2016-07-08

Primary completion

2018-05-21

Completion

2020-10-07

Outcome

Met primary endpoint

paper A PFS12 of 55% was observed in the EC cohort and 50% in the OC cohort. PMID 33109627 ↗

Publications

• Colon-Otero G, Zanfagnin V, Hou X, Foster NR, Asmus EJ, Wahner Hendrickson A, Jatoi A, Block MS, Langstraat CL, Glaser GE, Dinh TA, Robertson MW, Camoriano JK, Butler KA, Copland JA, Weroha SJ. Phase II trial of ribociclib and letrozole in patients with relapsed oestrogen receptor-positive ovarian or endometrial cancers. ESMO Open. 2020 Oct;5(5):e000926. doi: 10.1136/esmoopen-2020-000926.

Drugs

Indications