A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Breast cancer that is locally advanced or metastatic
HER2 negative disease, and a known hormone receptor status - ER/PgR (common breast cancer classification tests)
A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
Adequate bone marrow and organ function
Measurable or non-measurable disease
You may not be if
Prior chemotherapy for locally advanced or metastatic disease
Previous treatment with PI3K or AKT inhibitors
Patient has symptomatic CNS metastases
Concurrent malignancy or malignancy within 3 years of study enrollment
Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to starting study drug
Increasing or chronic treatment (\> 5 days) with corticosteroids or another immunosuppressive agent
Active heart (cardiac) disease as defined in the protocol
Known hypersensitivity or contraindications to use paclitaxel
Pregnant or nursing (lactating) woman
Certain scores on an anxiety and depression mood questionaire given at screening
Other protocol defined criteria may apply
Clareo Health | A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
