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

NCT03532087 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-01-18

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Denosumab 120 mg

Denosumab 120 mg every 3 weeks.

DRUG

Denosumab 60 mg

Denosumab 60 mg every 6 months.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Borstkanker Onderzoek Groep

    lead NETWORK

Principal Investigators

  • Judith R Kroep, MD PhD · Leiden University Medical Center

  • Gerrit-Jan Liefers, MD PhD · Leiden University Medical Center

  • Sjoerd H van der Burg, Prof. Dr. · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2021-02-28
Completion
2023-06-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532087 on ClinicalTrials.gov