Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Inclusion Criteria:

- Must have histologically or cytologically confirmed clinical stage T2-3 N0-2 triple
negative (estrogen receptor/progesterone receptor <1% human epidermal growth factor
receptor 2 (HER2) 0-1 by ImmunoHistoChemistry (IHC) or unamplified by fluorescence in
situ hybridization (FISH)) invasive ductal carcinoma.

- 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 CT scan. As well, participants must
have primary tumor able to be visualized on ultrasound and amenable to direct
injection.

- No prior history of an invasive breast cancer

- Adults ages 18-70

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

- Must have normal organ and marrow function as outlined in protocol

- Sexually active women of child-bearing potential and men must agree to use adequate
contraception prior to study entry and for the duration of study participation.

- 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

- A second active malignancy, exceptions are localized non-melanoma skin cancers or
prior in situ carcinoma

- 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

- Known active or prior herpes simplex virus infections (HSV), prior complications from
HSV infections such as encephalitis, or require systemic antiviral therapy at the time
of study enrollment

- 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.

- Women who are pregnant or nursing

- Immunocompromised patients may be at increased risk of herpetic infections when
treated with talimogene laherparepvec. Therefore, 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. Seasonal influenza
vaccines for injection are generally killed virus vaccines and are allowed. However,
intranasal influenza vaccines (eg, Flu - Mist®) are live attenuated vaccines, and are
not allowed.