drugset / Trial / NCT01953445

Paclitaxel and BKM120 Before Surgery in Treating Patients With Stage II or III Estrogen Receptor-Positive and HER2-Negative Breast Cancer

NCT01953445

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the effects of paclitaxel combined with phosphoinositide 3-kinase (PI3K) inhibitor BKM120 in patients with stage II or III breast cancer that is described as estrogen receptor-positive, human epidermal growth factor 2 (HER2)-negative and endocrine therapy resistant. Drugs such as paclitaxel stop the growth of tumors by blocking cancer cell division. PI3K inhibitor BKM120 inhibits some of the enzymes needed for cell growth and may improve the response of endocrine resistant tumors to treatment. Giving paclitaxel and PI3K inhibitor BKM120 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Timeline

Start
2014-08
Primary completion
2015-06
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Buparlisib Small molecule Oral
Subject Paclitaxel Small molecule Intravenous

Indications