NCT03820141

Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer

Multicenter Phase II Trial of Durvalumab (MEDI4736) With Trastuzumab and Pertuzumab Combination in HER2-Enriched and HER2-Amplified Breast Cancer (DTP Trial)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (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 using durvalumab with trastuzumab and pertuzumab in participants with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	programmed cell death-ligand 1 inhibitor
DRUG	Trastuzumab	anti-HER2 monoclonal antibody
DRUG	Pertuzumab	anti-HER2 monoclonal antibody

Timeline

• Start date: 2020-06-30
• Primary completion: 2024-10-30
• Completion: 2028-12-01
• First posted: 2019-01-29
• Last updated: 2026-04-20
• Results posted: 2026-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study