A phase III trial of alpelisib + trastuzumab ± fulvestrant versus trastuzumab + chemotherapy in HER2+ PIK3CA -mutated breast cancer.
José Alejandro Pérez-FidalgoCarmen CriscitielloEva CarrascoMeredith M ReganAngelo Di LeoKarin RibiVirginie AdamPhilippe L BedardPublished in: Future oncology (London, England) (2022)
ALPHABET is a randomized phase III trial assessing alpelisib + trastuzumab with or without fulvestrant in previously treated HER2-positive PIK3CA -mutated advanced breast cancer. Patients will be included in two cohorts according to hormone receptor (HR) status. In the experimental arms, patients in the HR-negative cohort will receive trastuzumab + alpelisib, and patients in the HR-positive cohort will receive the same treatment plus fulvestrant. Patients in the control arms will receive trastuzumab + physician's choice chemotherapy (eribuline, capecitabine or vinorelbine). Key eligibility criteria include 1-4 previous lines of anti-HER2 therapy and prior trastuzumab emtansine. The primary end point is investigator-assessed progression-free survival. The study aims to recruit a total of 300 patients.
Keyphrases
- phase iii
- end stage renal disease
- ejection fraction
- metastatic breast cancer
- newly diagnosed
- clinical trial
- chronic kidney disease
- epidermal growth factor receptor
- prognostic factors
- peritoneal dialysis
- primary care
- emergency department
- open label
- randomized controlled trial
- study protocol
- mesenchymal stem cells
- tyrosine kinase
- young adults
- rectal cancer
- locally advanced
- positive breast cancer