NCT04095689

Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer

Phase II Study of Docetaxel Chemotherapy With Pembrolizumab and Interleukin-12 Gene Therapy in Patients With Anthracycline- Refractory Triple Negative Breast Cancer (INTEGRAL)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Triple Negative Breast Cancer
• Anthracycline-refractory TNBC

Interventions

Type	Name	Description
DRUG	Docetaxel	Microtubule-targeting drug (inhibits microtubule depolymerization)
DRUG	Pembrolizumab	Programmed cell death-1 (PD-1) inhibitor
DRUG	IL-12 gene therapy	Adenoviral-mediated IL-12

Timeline

• Start date: 2021-05-12
• Primary completion: 2024-06-03
• Completion: 2024-06-03
• First posted: 2019-09-19
• Last updated: 2026-01-23
• Results posted: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study