Phase II basket study of an ARomatase inhibitor plus PI3KCA inhibitor or CDK4/6 inhibitor in women with hormone receptor positive recurrent/metastatic Gynaecological Neoplasms (PARAGON-II)

Abstract

The PARAGON-II clinical trial seeks to improve outcomes for post-menopausal women with advanced (recurrent and/or metastatic) gynaecological cancers, that are hormone-receptor positive. The study aims to investigate if the combination treatments of letrozole plus alpelisib, and letrozole plus ribociclib, will lead to an increase in overall response rates, as compared to historical controls from the PARAGON trial, in HR+ advanced gynaecological cancers that are either PIK3CA-mutated or PIK3CA non-mutated.

Who is it for? You may be eligible for this study if you are aged 18 or older, with advanced (recurrent and/or metastatic) gynaecological cancers, that are hormone-receptor positive.

Study details Participants will be allocated to one of the two treatment groups based on the PIK3CA mutation status, then followed-up to see if outcomes are improved and what side-effects occur.

Clinical assessment, imaging, blood tests will be performed. CA125 tumour and Patient Reported Outcomes will be also be assessed during the study.

It is hoped that combination treatments of letrozole plus alpelisib, and letrozole plus ribociclib, will lead to an increase in overall response rates in HR+ advanced gynaecological cancers that are either PIK3CA-mutated or PIK3CA non-mutated.