A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer
Condition: Breast Neoplasms; Breast Cancer; Cancer of the Breast
MeSH terms: Breast Neoplasms
Intervention: Lapatinib and Everolimus
Intervention description: Lapatinib: 1250 mg by mouth daily
Everolimus: 5mg by mouth daily
Intervention MeSH terms: Everolimus; Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic breast cancer; Triple negative breast cancer; Estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2)-negative breast cancer

Summary:

      The patient is being asked to join this clinical research study to find out if lapatinib, an
      agent that targets a protein, called epidermal growth factor receptor (EGFR) on the surface
      of cancer cells in combination with everolimus, an agent that targets a protein in the cancer
      cell, called mammalian target of rapamycin (mTOR) is effective in metastatic triple negative
      breast cancers that are no longer controlled by standard chemotherapy.
    

Eligibility criteria:

        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 Response Evaluation Criteria in Solid Tumors (RECIST)
             criteria

          -  Age >18 years old

          -  Female

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Left ventricular ejection fraction (LVEF) > 50%

          -  Absolute neutrophil count (ANC)>1500/mm3; platelets >100,000/mm3; hemoglobin > 9 g/dL;
             serum creatinine < 1.5x upper limit of normal (ULN); total bilirubin < 1.5x ULN,
             aspartate aminotransferase (AST) and alanine aminotransferase (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 central nervous system (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)