The purpose of this research study is to test the safety and effectiveness of docetaxel chemotherapy and pembrolizumab plus adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with anthracycline-refractory, triple negative breast cancer (TNBC).
The purpose of this study is to learn how triple negative breast cancer (TNBC) responds to the use of chemotherapy, pembrolizumab, and gene therapy together in patients who have previously not responded to treatment. We will also look at the effects, good or bad, the study therapy has on you and your TNBC. Chemotherapy given before breast cancer surgery is called neoadjuvant chemotherapy. It shrinks the breast tumor, so it is easier to remove during surgery. Docetaxel is often used for the neoadjuvant treatment of breast cancer. Unfortunately, a lot of breast tumors do not shrink with docetaxel chemotherapy treatment. Docetaxel chemotherapy is standard care for TNBC. Pembrolizumab is a type of treatment that stimulates your own immune system to attack cancer cells. Your immune system is normally your body's first defense against threats like cancer. However, sometimes cancer cells produce signals that prevent the immune system from detecting and killing them. Pembrolizumab helps your immune system so it can detect and attack cancer cells. Chemotherapy plus pembrolizumab has been shown to be better than chemotherapy alone for shrinking breast tumors before surgery. To help increase the tumor-shrinking activity of docetaxel chemotherapy and pembrolizumab, you will be given more treatments, Interleukin-12 (IL-12) gene therapy This treatments will be used to boost the cancer-fighting ability of your immune system. Thus, the use of IL-12 gene therapy with docetaxel chemotherapy and pembrolizumab may make your immune system work harder to shrink your tumor. IL-12 is a substance that is normally made by certain immune cells in the body. IL-12 stimulates T cells, a special type of immune cell in the blood, to respond to threats to your body like cancer. After you finish the study treatment, you will have your breast cancer surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Microtubule-targeting drug (inhibits microtubule depolymerization)
Programmed cell death-1 (PD-1) inhibitor
Adenoviral-mediated IL-12
Houston Methodist Cancer Center
Houston, Texas, United States
Pathological Complete Response (pCR) Rate of Docetaxel Chemotherapy and Pembrolizumab Plus IL-12 Gene Therapy
To determine the pCR rate of docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy in patients with TNBC per RECIST v1.1 assessed by CT Scan or MRI. CR: Disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, using the baseline sum longest diameter as a reference. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, using the smallest sum longest diameter as a reference. PD: At least a greater than or equal to 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Clinical PD: Patients who in the opinion of the treating PI have clinical evidence of PD may be classified as having PD
Time frame: 18 weeks
Number of Participants With Treatment-related Adverse Events
To determine the number of participants with treatment-related adverse events, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Time frame: 18 weeks
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