drugset / Trial / NCT03554044

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

NCT03554044

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase Ib trials studies the side effects and how well talimogene laherparepvec works when given together with chemotherapy or endocrine therapy in treating patients with breast cancer that does not express the human epidermal growth factor receptor 2 (HER2) protein and has spread to other places in the body (metastatic), cannot be removed by surgery (unresectable), or has come back (recurrent). Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Chemotherapy drugs, such as nab-paclitaxel, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Estrogen can cause the growth of breast cancer cells. Drugs used as endocrine therapy, such as letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, may lessen the amount of estrogen made by the body or may may stop the growth of tumor cells by blocking estrogen from connecting to the cancer cells. Giving talimogene laherparepvec with chemotherapy or endocrine therapy may work better in treating patients with HER2-negative breast cancer.

Timeline

Start
2020-02-05
Primary completion
2023-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Anastrozole Other / unclassified Oral
Subject Carboplatin Small molecule Intravenous
Subject Exemestane Small molecule Oral
Subject Fulvestrant Small molecule Intramuscular
Subject Gemcitabine Small molecule Intravenous
Subject Letrozole Other / unclassified Oral
Subject Paclitaxel Small molecule Intravenous
Subject Talimogene Laherparepvec Other / unclassified Other
Subject Tamoxifen Small molecule Oral