A Phase Ib/II, open label, multi-center study evaluating the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab

Summary:
Trastuzumab is a medicine that is currently available and a treatment you must have previously received for your cancer and failed in order to be eligible for this trial. Trastuzumab is used for the treatment of patients with breast cancer who have tumors that produce large amounts of HER2, which is a protein mainly found on the surface of these cancer cells. Stimulation of this HER2 protein can cause the growth of the cancer cells. When the drug trastuzumab binds to HER2, it stops this stimulation to these cells.
The purpose of this study is to investigate new treatment options for patients like you with HER2 overexpressing locally advanced or metastatic (spreading to the rest of body) breast cancer. The study will combine BKM120 and trastuzumab and you may be asked to join the first part called “Phase I” or the second part called “Extended or Phase II”.
BKM120 is an experimental medicine which has not been approved by the Food and Drug Administration for the treatment of people with your medical condition. More than 100 subjects with various types of cancer have been treated with BKM120 (either as single treatment or in combination with another drug) in clinical studies. It is expected that the combination of BKM120 and trastuzumab may cause your tumor to stop growing or possibly shrink your tumor. This assessment will be based on measuring changes in the size of your tumor.

Eligibility and Treatment Plan:

• Male and female of at least 18 years old
• Have HER2 + breast cancer (locally advanced or metastatic) and documented evidence of progressive disease
• No contraindication to trastuzumab treatment; or tolerance to previous  trastuzumab treatment
• No impairment of gastrointestinal (GI) function or GI disease that may affect the absorption of BKM120
• Negative serum (blood) pregnancy test

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