Interferon Gamma-1b, Paclitaxel, Trastuzumab, and Pertuzumab in Treating Patients with HER-2 Positive Breast Cancer

Inclusion Criteria

• Patients must have a histologically confirmed HER2 positive breast cancer (by immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization [FISH] ratio >= 2.0) * Phase I: unresectable locally advanced or metastatic breast cancer * Phase II: clinical stage 1-3 early stage breast cancer with primary tumor is at least 1 cm measured by clinical exam or by radiologic breast imaging tests
• Phase I: patients must be candidates to receive paclitaxel chemotherapy in combination with trastuzumab and pertuzumab * Phase II: no prior chemotherapy, radiation, or definitive therapeutic surgery (e.g., mastectomy, lumpectomy or axillary dissection) for this malignancy; patients who have had a prior sentinel lymph node biopsy for this malignancy are eligible * Note: patients who receive equal to or less than 1 cycle of therapy (up to 4 weeks) will be allowed to enroll on this trial
• Patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for the prevention or treatment of breast cancer or for other indications (e.g., osteoporosis, prior ductal carcinoma in situ [DCIS]), or who receive aromatase inhibitors for prevention or treatment of breast cancer, are eligible; patients who are hormone-receptor positive and who have received other hormonal agents for the treatment of breast cancer (e.g., Fulvestrant) are also eligible; tamoxifen therapy or other hormonal agents should be discontinued at least 1 week before the patient is started on study therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Absolute neutrophil count (ANC) >= 1,500/uL (within 2 weeks of registration)
• Platelets >= 100,000/uL (within 2 weeks of registration)
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be < 3.0 mg/dL (within 2 weeks of registration)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (within 2 weeks of registration)
• Left ventricular ejection fraction (LVEF) ejection fraction (EF) >= of 50% (by echocardiogram or multigated acquisition [MUGA] scan within 12 weeks of registration)
• Creatinine =< 1.5 x institutional upper limit of normal (ULN) (within 2 weeks of registration)
• Electrocardiogram (ECG) - corrected QT (QTc) < 480 msec (within 2 weeks of registration)
• Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria

• Patients may not be receiving any other investigational agents during protocol therapy, or up to 14 days or 5 half-lives (whichever is longer) prior to beginning protocol therapy; there should be a least a 1-week interval between last dose of endocrine therapy and protocol therapy
• Patients who have had chemotherapy or radiation therapy within 2 weeks prior to beginning protocol therapy
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Current use of corticosteroid therapy > 5 mg/day of prednisone or equivalent doses of other corticosteroids (topical, intranasal, and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed)
• Patients with known active or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis; asymptomatic, treated, and/or stable brain metastases, as measured by subsequent radiologic evaluations at least two months apart, are permitted
• Pregnant or breast feeding
• Known human immunodeficiency virus (HIV)-positive
• Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
• Major surgery within 4 weeks of initiation of study drug
• Second invasive malignancy requiring active treatment