Studieoverzicht - 2008-01 2-2-6 G-CSF

Number 2008-01 2-2-6 G-CSF
Nickname 2-2-6 G-CSF
Status Closed Date: 15-12-2009
Inclusion closed
Other study number(s) ZonMW
Participating parties/groups
Full title Primary G-CSF prophylaxis during the first two cycles only or throughout all chemotherapy cycles in breast cancer patients at risk of febrile neutropenia. Prospective randomised phase III study and HTA methodology study
Phase and type Randomized Phase III
Age ≥ 18
Menopausal status Both pre- and postmenopausal
Indication Adjuvant
Subindication Any HER2, any HR
Target sample size 230
Actual accrual 163 Date: 15-12-2009
Estimated study completion date 15-12-2009
CCMO approval Date: Nr:
EudraCT nr. 2007-005402-53
Trial Register NCT00536081
METC approval Yes Date: METC: Academisch Ziekenhuis Maastricht Nr:
Amendments No Date:
KWF-CKS approval No Date: Nr:
News item
Sponsor MUMC
Principal Investigator(s) V.C.G. Tjan-Heijnen
Study manager
Central datamanagement and randomization Trialoffice IKO
Radboud University Nijmegen, Medical Centre
PO Box 9101, HP 485
6500 HB Nijmegen
Tel 024 361 68 37
Fax 024 361 90 80
Local datamanagement
Funding logo ZonMW.gifFunding by ZON-MW


Arm A (standard arm): 6 cycles of doxorubicin-docetaxel containing chemotherapy with G-CSF support
in cycles 1 through 6 versus
Arm B (experimental arm): 6 cycles of doxorubicin-docetaxel containing chemotherapy with G-CSF
support only in cycles 1 and 2.

To determine the most cost-effective strategy of primary G-CSF prophylaxis

Primary clinical endpoint:

  • Incidence of febrile neutropenia

The primary economic endpoint:

  • costs per treatment arm

Secondary endpoints:

  • QoL
  • Chemotherapy dose
  • Dose-intensity
Main eligibility criteria:

Breast cancer patients who will be treated with doxorubicin-docetaxel chemotherapy, 3-weekly chemotherapy, being at risk of FN according to criteria of international guidelines

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