Studieoverzicht - 2006-06 ATX

Number 2006-06 ATX
Nickname ATX
Status Closed Date: 03-12-2010
Inclusion closed
Other study number(s)
Participating parties/groups
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.
Phase and type Randomized Phase II
Age ≥ 18 and ≤ 75
Menopausal status Both pre- and postmenopausal
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
CCMO approval Yes Date: 02-04-2007 Nr: NL17213.029.07
EudraCT nr. 2006-006058-83
Trial Register NTR1348
METC approval Yes Date: 25-05-2007 METC: Vrije Universiteit Medisch Centrum Nr: 2007/72
Amendments Date:
KWF-CKS approval No Date: Nr:
News item
Sponsor Vumc, BOOG
Principal Investigator(s) E. Boven, A.H. Honkoop
Study manager A.E. van Leeuwen-Stok
Central datamanagement and randomization IKNL locatie Amsterdam, Trialbureau
PO Box 9236
1006 AE Amsterdam
Tel 020 3462544
Fax 020 3462597
Monitoring BOOG via SMS-Oncology
Local datamanagement


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


To investigate Progression Free Survival (PFS)


Primary endpoint:

  • Progression free survival

Secondary endpoints:

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

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