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ATX

  • Closed

BOOG 2006-06

General Information

BOOG number

BOOG 2006-06

Nickname

ATX

Status

  • Closed
Date: 03/12/2010

Full title

Phase II randomized trial of combination therapy of paclitaxel and bevacizumab versus paclitaxel, capecitabine and bevacizumab as first-line treatment for locally recurrent or metastatic breast cancer patients with HER2/neu negative tumor.

Indication

  • Advanced/Metastatic

Subindication

HER2-, any HR

Target sample size

312

Actual accrual

312
Date: 03/12/2010

Estimated study completion date

31/12/2010

Contact

Sponsor

Vumc, BOOG

Principal Investigator(s)

E. Boven, A.H. Honkoop

Study manager

A.E. van Leeuwen-Stok

Central datamanagement and randomization

IKNL trialbureau@iknl.nl

Tel 020 3462544

Monitoring

BOOG via SMS-Oncology

Design

Randomization: Arm A: paclitaxel and bevacizumab. Arm B: paclitaxel, capecitabine and bevacizumab

Objectives

To investigate Progression Free Survival (PFS)

Endpoints

Primary endpoint:

  • Progression free survival

Secondary endpoints:

  • Overall response rate
  • Duration of respons
  • Overall survival
  • Safety

Eligibility Criteria

Patients with histologically or cytologically confirmed, HER2/neu-negative, pre- or postmenopausal adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to resection and/or radiotherapy with curative intent

Regulatory Information

CCMO approval

Yes
Date: 02/04/2007
Nr: NL17213.029.07

EC approval

Yes
Date: 25/05/2007
Nr:2007/72

EC

Vrije Universiteit Medisch Centrum

EudraCT number

2006-006058-83

Trial Register

NTR1348

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