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2-2-6 G-CSF

  • Closed

BOOG 2008-01

General Information

BOOG number

BOOG 2008-01

Nickname

2-2-6 G-CSF

Status

  • Closed
Date: 15/12/2009

Other study number

ZonMW

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

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

Contact

Sponsor

MUMC

Principal Investigator(s)

V.C.G. Tjan-Heijnen

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 E-mail trialiko@onco.umcn.nl

Funding

Funding by ZON-MW

Design

Randomization: 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.

Objectives

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

Endpoints

Primary clinical endpoint:

  • Incidence of febrile neutropenia

The primary economic endpoint:

  • costs per treatment arm

Secondary endpoints:

  • QoL
  • Chemotherapy dose
  • Dose-intensity

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

Regulatory Information

CCMO approval

Yes

EC approval

Yes

EC

Academisch Ziekenhuis Maastricht
Amendments:
No

EudraCT number

2007-005402-53

Trial Register

NCT00536081

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