A new clinical study at the National Cancer Institute in the U.S. is looking into a treatment method for patients with a specific type of breast cancer that is either too spread out (metastatic), cannot be surgically removed (unresectable), or has returned after treatment (recurrent).
The breast cancer study in question does not have the HER2 protein, which is a common target for some breast cancer therapies. The treatment being tested combines a biological therapy called talimogene laherparepvec with either chemotherapy or endocrine therapy.
Talimogene laherparepvec is a kind of treatment made from living organisms, specifically designed to target and kill cancer cells directly or stop them from growing.
Chemotherapy, with drugs like nab-paclitaxel, gemcitabine, and carboplatin, kills cancer cells or stops them from dividing and spreading by different mechanisms.
Endocrine therapy, using drugs like letrozole, anastrozole, exemestane, tamoxifen, or fulvestrant, targets the cancer cells by lowering estrogen levels in the body or blocking estrogen from supporting the growth of cancer cells, as some breast cancers grow faster with estrogen.
The main goal of this study (Phase Ib) is to check how safe and tolerable it is to give talimogene laherparepvec via direct injection into the cancer lesion along with either chemotherapy or endocrine therapy.
The researchers also want to see how effective this combination is in treating the cancer, using specific criteria to measure the response of the tumors to the treatment.
The study has two groups of patients. One group will receive talimogene laherparepvec with chemotherapy, and the other group will get it with endocrine therapy. The way talimogene laherparepvec and the other drugs are given, and the schedule for each treatment, vary depending on the group.
Additionally, the study will look into how the treatment affects the immune system’s response to cancer by examining immune biomarkers, which are substances that can indicate the state of the immune system and how it’s reacting to the cancer. They’re also interested in seeing if the treatment causes any changes in the body’s response to the herpes simplex virus type 1, as talimogene laherparepvec is related to this virus.
After the treatment is completed, the patients will be followed up for a month to monitor any late side effects or the treatment’s long-term effectiveness.
