A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative [HR+/HER2-] Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor (NCT06982521)

This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Maggie Moore

Key inclusion data

18 Years and older.  Histologically or cytologically confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the breast with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent. Tumor must be ER positive with or without co-expression of progesterone receptor, and HER2- as confirmed by local laboratory testing. One or more known primary oncogenic PIK3CA mutation(s) in tissue or blood documented per validated local assessment and confirmed by central testing of ctDNA by NGS prior to randomization. Measurable disease per RECIST v.1.1 or evaluable bone-only disease.