Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

The overall aim of this project is to help improve the Health Related Quality of Life (HRQOL) of metastatic breast cancer (MBC) patients. There is currently an urgent and unmet need for specific tools to aid in the evaluation of HRQOL in MBC and this project aims to address these needs by developing a comprehensive EORTC questionnaire for assessing the HRQOL of this group. The new module will be used in conjunction with EORTC QLQ-C30 and will provide better measurement of the quality of life issues experienced by women with MBC. Interviews will be conducted with patients from several centres across Europe, guiding the development process in a patient centred way.

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.

Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage Dose Escalation Phase followed by a Dose Expansion Phase.

The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.