Study on Talimogene Laherparepvec and Chemotherapy Before Surgery for Triple Negative Breast Cancer

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02779855

Provider View

This clinical trial is exploring whether injecting an oncolytic virus called Talimogene laherparepvec directly into the tumor during chemotherapy can help eliminate triple negative breast cancer more effectively before surgery.

Patient Parameters

Program Overview

The study aims to find out if using an oncolytic virus, Talimogene laherparepvec, in combination with chemotherapy can better destroy triple negative breast cancer tumors before surgery. This virus is a modified version of the herpes simplex virus, which usually causes cold sores, but has been changed to target and break down cancer cells while leaving normal cells unharmed. It is believed that the virus can also help the immune system attack cancer cells, potentially making the treatment more effective than chemotherapy alone. Talimogene laherparepvec is already approved for treating melanoma skin tumors, and researchers want to see if it can provide similar benefits for women with triple negative breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with triple negative breast cancer, specifically stage T2-3 N0-2 invasive ductal carcinoma.
  • Have at least one tumor that can be measured and is suitable for direct injection.
  • No previous history of invasive breast cancer.
  • Aged between 18 and 70 years old.
  • In good general health with an ECOG performance status of 0 or 1.
  • Normal organ and bone marrow function.
  • Sexually active participants must agree to use effective birth control during the study.
  • Able to understand and willing to sign a consent form.

Exclusion Criteria

  • Have T4 tumors, metastatic disease, recurrent disease, inflammatory breast cancer, or multiple breast cancers.
  • Have another active cancer, except for certain skin cancers or previous in situ carcinoma.
  • Currently receiving other experimental treatments or unable to take specific chemotherapy drugs.
  • Allergic to Talimogene laherparepvec or similar treatments.
  • Have a history of herpes simplex virus infections or complications from such infections.
  • Have uncontrolled illnesses, such as active infections, heart problems, or psychiatric conditions.
  • Pregnant or breastfeeding women.
  • Have a weakened immune system, including HIV-positive individuals or those on high-dose immunosuppressants.
  • Have received live vaccines within 28 days before starting the study, except for certain flu shots.

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