A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed ER(-), PR(-), HER2(-) locally advanced or
metastatic breast cancer

- Disease progression following prior first line cytotoxic chemotherapy in metastatic
setting

- At least 1 lesion measurable by RECIST criteria

- Age >18 years old

- Female

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Left ventricular ejection fraction (LVEF) > 50%

- ANC>1500/mm3; platelets >100,000/mm3; hemoglobin > 9 g/dL; serum creatinine < 1.5X
ULN; total bilirubin < 1.5X ULN, AST and ALT < 2.5X ULN

- Patients must be recovered from both acute and late effects of any prior surgery,
radiotherapy or other antineoplastic therapy

- Patients or their legal representatives must be able to read, understand and provide
informed consent to participate in the trial.

- Patients of childbearing potential agree to use an effective form of contraception
during the study and for 90 days following the last dose of study medication (an
effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria:

- Patients with current active hepatic or biliary disease (except for patients with
Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver
disease per investigator assessment)

- Patients with an active infection or with a fever > 101.3 Fahrenheit within 3 days of
the first scheduled day of protocol treatment

- Patients with active CNS metastases. Patients with stable CNS disease, who have
undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment
and who have been on a stable dose of corticosteroids for 3 weeks are eligible for
the trial

- History of prior malignancy within the past 5 years except for curatively treated
basal cell carcinoma of the skin or cervical intra-epithelial neoplasia with two
consecutive normal pap smears 6 months apart

- Patients who received radiotherapy to more than 25% of their bone marrow; or patients
who received radiotherapy to target lesions within 4 weeks of entry

- Patients who are receiving concurrent investigational therapy

- Peripheral neuropathy >= Grade 2

- Patients who are pregnant or lactating

- Any other medical condition, including mental illness or substance abuse, deemed by
the Investigator to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interfere with the interpretation
of the results.

- History of allogeneic transplant

- Known HIV or Hepatitis B or C (active, previously treated or both)