Studieoverzicht - 2017-02 PERIDENO

 
Number 2017-02 PERIDENO
Nickname PERIDENO
Status Closed Date: 11-10-2018
Inclusion closed
Other study number(s) not started
Participating parties/groups
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
Phase and type Randomized Phase II
Age ≥ 18
Menopausal status Postmenopausal
Indication Adjuvant
Subindication HER2-, any HR
Target sample size 75
Actual accrual 0 Date: 11-10-2018
Estimated study completion date 01-10-2022
CCMO approval Yes Date: 21-12-2017 Nr: NL62335
EudraCT nr. 2016-005210-22
Trial Register NCT03532087
METC approval Yes Date: 25-04-2018 METC: Leiden Universitair Medisch Centrum Nr: NL62335.058.17
Amendments Submitted Date:
KWF-CKS approval Not applicable Date: Nr:
News item
Website
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
datacenter@lumc.nl | 071-5263500
Monitoring LUMC datacenter
071-5263500
Local datamanagement IKNL or Site
Funding Amgen
Extra Please note that the PERIDENO study will not be continued. Coordinating investigator/project leader: A.F. de Groot (Leids Universitair Medisch Centrum)

Design:

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.
Endpoints:
Main eligibility criteria:
Documents (public):

Protocol synopsis

Documents (protected):
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