NCT03874325

Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

A Phase II Trial With Safety Run-in of Neoadjuvant Therapy With an Aromatase Inhibitor in Combination With Durvalumab (MEDI4736) in Postmenopausal Patients With Hormone-Receptor-Positive Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to find out if an investigational drug called Durvalumab (MEDI4736) given together with a standard of care aromatase inhibitor drug can help people with breast cancer.

Conditions

• Breast Cancer
• Hormone Receptor Positive Tumor

Interventions

Type	Name	Description
DRUG	Durvalumab	1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.
DRUG	Anastrozole 1mg	Participants will self administer 1 mg anastrozole by mouth daily for 6 months.
DRUG	Letrozole 2.5mg	Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.
DRUG	Exemestane 25 MG	Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Timeline

• Start date: 2019-04-26
• Primary completion: 2020-11-15
• Completion: 2021-01-06
• First posted: 2019-03-14
• Last updated: 2022-05-31
• Results posted: 2022-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study