Talimogene Laherparepvec and Combination Chemotherapy in Treating Patients with Triple Negative Breast Cancer before Surgery

Inclusion Criteria

• Patients must have histologically or cytologically confirmed clinical stage T2-3 N0-2 triple negative (estrogen receptor/progesterone receptor < 1% HER2 0-1 by immunohistochemistry [IHC] or unamplified by fluorescence in situ hybridization [FISH]) invasive ductal carcinoma
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; as well, patients must have primary tumor able to be visualized on ultrasound and amenable to direct injection
• No prior history of an invasive breast cancer
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >= 70%)
• Leukocytes >= 3,000/uL
• Absolute neutrophil count >= 1,500/uL
• Platelets >= 100,000/uL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• Multi-gated acquisition (MUGA) scan or echocardiogram (ECHO) >= ejection fraction (EF) of 50%
• The effects of talimogene laherparepvec on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because the other therapeutic agents used in this trial are known to be teratogenic, sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 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 the willingness to sign a written informed consent document

Exclusion Criteria

• T4 tumors, known metastatic disease, recurrent disease, inflammatory breast cancer, multicentric disease, and/or synchronous bilateral breast cancer
• Patients with a second active malignancy, exceptions are localized non-melanoma skin cancers or prior in situ carcinoma
• Patients receiving any other investigational agents or are unable to be treated with doxorubicin, cyclophosphamide, and paclitaxel
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to talimogene laherparepvec or other agents used in the study
• Patient with known active herpes simplex virus infections (prior uncomplicated oral herpes simplex virus [HSV] lesions are not an exclusion), prior complications from HSV infections such as encephalitis, or who require systemic antiviral therapy at the time of study enrollment should be excluded
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, known active hepatitis B/C infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patient on anticoagulation or with bleeding diathesis due to risk of hematomas at injection site
• Pregnant or nursing women are excluded from this study
• Immunocompromised patients may be at increased risk of herpetic infections when treated with talimogene laherparepvec; therefore, human immunodeficiency virus (HIV)-positive patients, patients with acquired or congenital immunodeficiency conditions, those on chronic systemic immunosuppressants (requiring > 10 mg of prednisone or equivalent/day)
• Those with active autoimmune disease are excluded from the study
• Have received any live vaccine therapies used for the prevention of infectious disease within 28 days prior to enrollment and during treatment period; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed