NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer

Summary

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).

Timeline

Start

2013-09-03

Primary completion

2015-02-18

Completion

2015-02-18

Outcome

Missed primary endpoint

paper Overall, pCR rate was similar between buparlisib and placebo arms (32.0% versus 40%; one-sided P = 0.811). PMID 28923573 ↗

registry analysis (superiority test); Trastuzumab + BKM120 + Paclitaxel vs Trastuzumab + BKM120 PBO + Paclitaxel; p = 0.830; Fisher Exact NCT01816594 ↗

registry analysis (superiority test); Trastuzumab + BKM120 + Paclitaxel vs Trastuzumab + BKM120 PBO + Paclitaxel; p = 0.786; Fisher Exact NCT01816594 ↗

Publications

• Loibl S, de la Pena L, Nekljudova V, Zardavas D, Michiels S, Denkert C, Rezai M, Bermejo B, Untch M, Lee SC, Turri S, Urban P, Kummel S, Steger G, Gombos A, Lux M, Piccart MJ, Von Minckwitz G, Baselga J, Loi S. Neoadjuvant buparlisib plus trastuzumab and paclitaxel for women with HER2+ primary breast cancer: A randomised, double-blind, placebo-controlled phase II trial (NeoPHOEBE). Eur J Cancer. 2017 Nov;85:133-145. doi: 10.1016/j.ejca.2017.08.020. Epub 2017 Sep 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buparlisib	Small molecule	100 mg	Oral
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Background	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous

Indications