A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole with or without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women with Hormone Receptor-positive HER2-Negative Breast Cancer

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A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole with or without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women with Hormone Receptor-positive HER2-Negative Breast Cancer

To assess the anti-tumor activity of BYL719 QD plus letrozole and buparlisib QD
plus letrozole versus letrozole alone in increasing the pathologic complete
response (pCR) rate during neo-adjuvant treatment among postmenopausal
patients with HR+, HER2-negative breast cancer for each of the two cohorts: i)
PIK3CA mutated and ii) PIK3CA wild type tumors.

Protocol Number041311
Principal InvestigatorDeborah Toppmeyer
PhasePhase II
ScopeNational
Applicable Disease SitesBreast - Female
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedBYL719/Placebo
LETROZOLE
buparlisib/Placebo
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.