PERIDENO

BOOG 2017-02

General Information

BOOG number

BOOG 2017-02

Nickname

PERIDENO

Status

Date: 11/10/2018

Other study number

not started

Full title

Explorative trial to identify the impact of DENOsumab on the systemic immunity and local immunologic microenvironment in postmenopausal patiënts with HER2 negative breast cancer

Indication

Subindication

HER2-, any HR

Target sample size

75

Estimated study completion date

01/10/2022

Contact

Sponsor

BOOG

Principal Investigator(s)

Dr. J.R. Kroep (Leids Universitair Medisch Centrum)

Study manager

Drs. A.F. de Groot, LUMC (studiecoördinator) T. Volker, MSc, BOOG Study Center (Project medewerker) Dr. A. E. van Leeuwen-Stok, BOOG Study Center (Clinical Study Manager)

Central datamanagement and randomization

Datacenter Heelkunde, LUMC, Postbus 9600 2300 RC Leiden, The Netherlands ClinicalResearchCenter@lumc.nl | 071-5263500

Monitoring

Clinical Research Center Lumc 071-5263500

Local datamanagement

IKNL or Site

Funding

Amgen

Other

Please note that the PERIDENO study will not be continued. Coordinating investigator/project leader: A.F. de Groot (Leids Universitair Medisch Centrum)

Objectives

Primary objective: Determine the change in intratumoral T-cell (CD4, CD8 and Treg) and Myeloid cell (M1/M2 Macrophage, MDSC, DC cell) numbers and function between the baseline biopsy and the surgical specimen. Secondary objectives: PBMC before start treatment, at day of surgery and 7 days after last chemotherapy administration: Determine the shift in T-cell (activated T effector cells and regulatory T cells) levels and function in PBMC samples. Determine the change in mature and immature myeloid cells (M1, M2, MDSC, DC). Determine the shift in myeloid cell function (IL-10 and IL-12 production after LPS or anti-CD40 triggering). Determine the change in stimulation capacity APCs (MLR + cytokine production after restimulation). Serum before start treatment, at day of surgery and 7 days after last chemotherapy administration): Determine the change in RANKL, OPG by ELISA; TNF-alpha, IL-1-beta, IL-6, IL-7, IL-10, IL-15, IL-12, IFN gamma by luminex. Tumor Correlate tumor (biopsy and resection material), serum and PBMC immunologic parameters. Toxicity according to NCI CTCAE v4.03. Determine the descriptive difference in disease free survival (DFS) at 3 year based on immune response.

Regulatory Information

CCMO approval

Yes
Date: 21/12/2017
Nr: NL62335

EC approval

Yes
Date: 25/04/2018
Nr:NL62335.058.17

EC

Leiden Universitair Medisch Centrum
Amendments:
Submitted

EudraCT number

2016-005210-22

Trial Register

NCT03532087

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