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TBP

  • Closed

BOOG 2004-02

General Information

BOOG number

BOOG 2004-02

Nickname

TBP

Status

  • Closed
Date: 01/06/2007

Participating parties / group

GBG, BIG

Other study number

GBG 26; BIG 3-05

Full title

A multicenter randomized phase III study to compare capecitabine alone or in combination with trastuzumab in patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab (Treatment Beyond Progression).

Indication

  • Advanced/Metastatic

Subindication

HER2+, any HR

Actual accrual

156
Date: 31/07/2007

Estimated study completion date

01/06/2007

Contact

Sponsor

GBG

Principal Investigator(s)

J.G.M. Klijn, J.W.R. Nortier

Monitoring

CRA BV

Other

TBP database was closed 14 april 2008. ISF bewaren t/m apr-2023.

 

http://www.germanbreastgroup.de/en/trials/palliative/tbp.html

Design

Randomization: Capecitabine alone or in combination with trastuzumab.

Objectives

To compare the time to disease progression in patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab randomized to capecitabine alone or in combination with trastuzumab.

Endpoints

Primary endpoint:

  • Time to progression.

Secondary endpoints:

  • Response rate
  • Duration of response
  • Clinical benefit (CR,PR, SD)
  • Safety combination
  • Overall survival

Eligibility Criteria

Locally advanced or metastatic stage of disease HER2-neu positive Progression after previous treatment with trastuzumab

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Nr:2004-17
Amendments:
Yes
Date Last Amendment: 23/05/2005

EudraCT number

2005-002084-85

Trial Register

NCT00148876

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