CompletedPhase 1/2

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

United States50 participantsStarted 2017-05-02

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 doxor…

What they're measuring

Phase I: Maximum Tolerated Dose (MTD) / Recommended Phase II Dose (RP2D)

Timeframe: Up to 6 months

Phase II: Percentage of Participants With Pathologic Complete Response Rate (pCR)

Timeframe: Up to 36 months

Trial details

NCT IDNCT02779855

SponsorH. Lee Moffitt Cancer Center and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-20

Results submitted2021-09-01