HER2-positive Newly Diagnosed, Primary Breast Cancer Clinical Trial
Official title:
NeoPHOEBE: Pi3k Inhibition in Her2 OverExpressing Breast cancEr: A Phase II, Randomized, Parallel Cohort, Two Stage, Double-blind, Placebo-controlled Study of Neoadjuvant Trastuzumab Versus Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive, PIK3CA Wild-type and PIK3CA Mutant Primary Breast Cancer
This randomized, parallel cohort, two stage, double-blind, placebo-controlled study evaluated the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in HER2-positive, PIK3CA wild-type and PIK3CA mutant primary breast cancer prior to surgery (neo-adjuvant setting).
NeoPHOEBE evaluated the efficacy (as defined by pCR) of BKM120 (an oral PI3K inhibitor) in
combination with trastuzumab and paclitaxel in a randomized, placebo-controlled, neo-adjuvant
study in women diagnosed with primary breast cancer >1.5 cm (by US or MRI) with centrally
confirmed HER2 overexpression or amplification, who have not previously undergone treatment
for invasive breast cancer.
Prior to the initiation of paclitaxel, there was a 6-week "biologic window" with trastuzumab
plus BKM120 or placebo only. The study was conducted separately in two cohorts (PIK3CA
mutated and PI3K3CA wild-type) using a two-stage approach. Within each cohort patients were
randomized into one of the following treatment arms:
Arm 1: BKM120 plus trastuzumab for 6 weeks followed by BKM120 and trastuzumab plus weekly
paclitaxel for an additional 12 weeks.
Arm 2: BKM120 placebo plus trastuzumab for 6 weeks followed by BKM120 placebo plus
trastuzumab plus weekly paclitaxel for an additional 12 weeks.
After completion of study treatment, patients were to have undergone definitive surgery.
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