The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer.
The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with HER2-enriched breast cancer. The standard or usual pre-surgery treatment for this type of disease are drugs called trastuzumab and pertuzumab that target HER2. Studies have shown that trastuzumab and pertuzumab treatment can stimulate the body's own immune system to attack cancer cells. Durvalumab is a drug that also activates the immune system. The use of durvalumab together with trastuzumab and pertuzumab treatment may allow the immune system to work harder to kill cancer cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
programmed cell death-ligand 1 inhibitor
anti-HER2 monoclonal antibody
anti-HER2 monoclonal antibody
Houston Methodist Cancer Center
Houston, Texas, United States
Pathological complete response (pCR) rate in the breast in patients with HER2-enriched and HER2-amplified breast cancer
Determine pCR rate in the breast in patients with HER2-enriched and HER2-amplified breast cancer
Time frame: 18 weeks
pCR rate in the breast in patients whose tumors have <5% and ≥5% tumor-infiltrating lymphocytes (TILs)
Determine pCR rate in the breast in patients whose tumors have \<5% and ≥5% TILs
Time frame: 18 weeks
pCR rate in patients with programmed cell death-ligand 1 (PD-L1)-positive and PD-L1-negative tumors
Determine pCR rate in the breast in patients with PD-L1-positive and PD-L1-negative tumors
Time frame: 18 weeks
Three-year disease-free survival (DFS) rate in patients who achieve pCR
Determination of 3-year DFS rate in patients who achieve pCR
Time frame: 3 years
Number of participants with treatment-related adverse events
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.