EPIK-B3: assessing the efficacy and safety of alpelisib+nab-paclitaxel
Research type
Research Study
Full title
EPIK-B3: A Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation.
IRAS ID
281219
Contact name
Mark Tuthill
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2019-002637-11
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 3 days
Research summary
Triple Negative Breast Cancer (TNBC)is an aggressive clinical subset of Breast Cancer define by the lack of estrogen
receptors (ERs) and progesterone receptors(PRs)and by human epidermal growth factor receptor 2 (HER2)-negative
status and accounts for 15% to 20% of newly diagnosed breast cancer cases. Phosphatase and tensin homolog
(PTEN) loss and phosphatidylinositol-3-kinase (PI3K) pathway mutations
appear to be generally mutually exclusive in TNBC.Alpelisib has proven to be acceptable with manageable, and
reversible AEs. The purpose of this study is to is to
determine if targeted therapy with the alpha-specific PIK3CA inhibitor, alpelisib, in
combination with nab-paclitaxel, is safe and effective in patients with advanced TNBC
harboring a PIK3CA mutation, or PTEN loss without a PIK3CA mutation.REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0143
Date of REC Opinion
9 Jul 2020
REC opinion
Further Information Favourable Opinion