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A Phase 1/2 Study of Talimogene laherparepvec in Combination with Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
The purpose of this study is to determine if an oncolytic virus called Talimogene laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells while leaving normal cells alone) injected directly into the tumor during chemotherapy prior to surgery can enhance the elimination of triple negative breast cancer tumors. The natural herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene laherparepvec version of the herpes virus has been changed to prevent it from reproducing in normal tissue. However, it can still attack and break open cancer tissue which is why it is used as a treatment for cancer. It is thought that this virus can also help recruit the participant's immune system to attack the cancer cells during their treatment and possibly destroy the tumor tissue more effectively than chemotherapy alone. This virus is already FDA approved to treat melanoma skin tumors, so investigators want to determine if this virus can achieve a similar benefit in women with triple negative breast tumors.
Primary Endpoint(s): Phase 1: Determine the MTD/RP2D of talimogene laherparepvec administered with neoadjuvant paclitaxel- doxorubicin/cyclophosphamide chemotherapy. Phase 2: Determine the efficacy (evaluated as pathologic complete response rates) of neoadjuvant talimogene laherparepvec in conjunction with neoadjuvant chemotherapy for early/locally advanced triple negative invasive breast cancer. Secondary Endpoints: Determine the safety and toxicity of the combination, 5 year recurrence free survival/overall survival, immune activation correlatives.
Adriamycin (doxorubicin); Nab-paclitaxel (Abraxane); Talimogene laherparepvec 10^6 PFU (Talimogene Laherparepvec); Talimogene laherparepvec 10^8 PFU (Talimogene Laherparepvec); Taxol (paclitaxel); cyclophosphamide (); cytoxan (cyclophosphamide); doxorubicin (); paclitaxel ()