Cold sore virus turned cancer assassin shows promise in tough breast cancer
NCT ID NCT02779855
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether injecting a modified herpes virus (T-VEC) directly into tumors, alongside standard chemotherapy before surgery, could better eliminate triple negative breast cancer. The virus is designed to infect and destroy cancer cells while leaving healthy cells alone, and may also help the immune system attack the tumor. The trial enrolled 50 women with early-stage triple negative breast cancer to find the safest dose and measure how many had no cancer left at surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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50 people
The number who actually took part.
- Started
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May 2017
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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