Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer (INTEGRAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04095689|
Recruitment Status : Suspended (protocol revisions, waiting for approval)
First Posted : September 19, 2019
Last Update Posted : April 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer Anthracycline-refractory TNBC||Drug: Docetaxel Drug: Pembrolizumab Drug: IL-12 gene therapy||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Docetaxel Chemotherapy With Pembrolizumab and Interleukin-12 Gene Therapy in Patients With Anthracycline- Refractory Triple Negative Breast Cancer (INTEGRAL)|
|Actual Study Start Date :||March 17, 2021|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||August 2024|
docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy.
Microtubule-targeting drug (inhibits microtubule depolymerization)
Other Name: Taxotere
Programmed cell death-1 (PD-1) inhibitor
Other Name: Keytruda
Drug: IL-12 gene therapy
- pathological complete response (pCR) rate of docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy [ Time Frame: 18 weeks ]To determine the pCR rate of docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy in patients with TNBC
- Number of participants with treatment-related adverse events [ Time Frame: 18 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095689
|United States, Texas|
|Houston Methodist Cancer Center|
|Houston, Texas, United States, 77030|