A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.
A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.
This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.
Based on the efficacy results at the time of the interim analyses, the DMC recommended stopping the study at Phase II during the interim as it met the protocol pre-specified futility criteria. Consequently, the Phase III portion of the study was not conducted.
Inclusion Criteria:
Exclusion Criteria:
Atlanta, Georgia 30322, United States
Albuquerque, New Mexico 87131, United States
Troy, New York 12180, United States
Columbus, Ohio 43210, United States
Dallas, Texas 75246, United States
San Antonio, Texas 78229, United States
Reston, Virginia 20190, United States
Hong Kong SAR, Hong Kong
Koto, Tokyo 135-8550, Japan
Kuei-Shan Chiang, Taoyuan/ Taiwan ROC 33305, Taiwan
Glasgow - Scotland, G12 OYN, United Kingdom