NCT03532087

Study to Identify the Impact of Denosumab on the Immune System in Patients With HER2 Negative Breast Cancer

Explorative Trial to Identify the Impact of Denosumab on the Systemic Immunity and Local Immunologic Microenvironment in Postmenopausal Patients With HER2 Negative Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Borstkanker Onderzoek Groep · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this prospective, randomized, multicenter, open-label, explorative phase II study is to identify the impact of (neo)adjuvant denosumab on the systemic immunity and local immunologic microenvironment in postmenopausal patients with HER2 negative non-metastatic primary breast cancer.

Detailed description

In this study, postmenopausal patients with stage T1c + grade 3, stage II or III, HER2-negative breast cancer, which are planned to undergo surgery followed by adjuvant AC-T chemotherapy, are randomized between no denosumab, denosumab low dosing and denosumab high dosing. Denosumab administration will start one week before surgery and continue until the last chemotherapy cycle.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Denosumab 120 mg	Denosumab 120 mg every 3 weeks.
DRUG	Denosumab 60 mg	Denosumab 60 mg every 6 months.

Timeline

• Start date: 2018-02-01
• Primary completion: 2021-02-01
• Completion: 2023-06-01
• First posted: 2018-05-22
• Last updated: 2020-01-18

Locations

8 sites across 1 country: Netherlands