Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage II or Stage III Triple-Negative Breast Cancer

The patients must have histologically confirmed breast cancer that is human epidermal growth factor receptor 2 (Her-2) negative (immunohistochemistry \[IHC\] 0-1+ patients are eligible without fluorescence in situ hybridization \[FISH\]; IHC2+ patients are eligible with negative FISH; if FISH only is done HER2/chromosome enumeration probe \[CEP\]17 \< 2.0); the invasive tumor must be hormone receptor negative defined as both estrogen receptor and progesterone receptor IHC staining present in less than 10% of invasive cancer cells

History of allergic reactions attributed to compounds of similar chemical or biologic composition to RO4929097 or other agents used in the study

Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin) are ineligible

Preclinical studies indicate that RO4929097 is a substrate of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) and inducer of CYP3A4 enzyme activity; caution should be exercised when dosing RO4929097 concurrently with CYP3A4 substrates, inducers, and/or inhibitors; furthermore, patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4 should be switched to alternative medications to minimize any potential risk; if such patients cannot be switched to alternative medications, they will be ineligible to participate in this study

Preclinical studies indicate that RO4929097 is a substrate of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and inducer of CYP2C8 enzyme activity; caution should be exercised when dosing RO4929097 concurrently with CYP2C8 substrates, inducers, and/or inhibitors; furthermore, patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of CYP2C8 should be switched to alternative medications to minimize any potential risk; if such patients cannot be switched to alternative medications, they will be ineligible to participate in this study

Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption; patients must be able to swallow tablets

Patients who are serologically positive for hepatitis A, B or C, or have a history of liver disease, other forms of hepatitis or cirrhosis are ineligible

Uncontrolled electrolyte abnormalities including hypocalcemia, hypomagnesemia,and hypokalemia; symptomatic congestive heart failure, unstable angina pectoris, and a history of torsades de pointes or other significant cardiac arrhythmias

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements

Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with RO4929097

Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Cardiovascular: baseline corrected QT interval (QTc) \> 450 msec in males or QTc \> 470 msec in females

A requirement for antiarrhythmics or other medications known to prolong QTc

What this study is about