Studieoverzicht - 2006-01 DATA

Number 2006-01 DATA
Nickname DATA
Status Follow up Date: 04-08-2009
Inclusion closed
Other study number(s) D5392-NL-003
Participating parties/groups
Full title A Prospective, randomised, open, multicenter, phase III study to assess different Duration of Anastrozole therapy after 2 to 3 years Tamoxifen as Adjuvant therapy in postmenopausal women with breast cancer.
Phase and type Randomized Phase III
Age > 45
Menopausal status Postmenopausal
Indication Adjuvant
Subindication Any HER2, HR+
Target sample size 1900
Actual accrual 1911 Date: 04-08-2009
Estimated study completion date 01-09-2009
CCMO approval Not applicable Date: Nr:
EudraCT nr. 2005-006167-31
Trial Register NCT00301457
METC approval Yes Date: 12-04-2006 METC: CMO Regio Arnhem-Nijmegen Nr: 2006/023
Amendments Yes Date: 12-04-2007
KWF-CKS approval No Date: Nr:
News item
Sponsor AstraZeneca
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
Monitoring AstraZeneca
Local datamanagement


Arm A: 3 years anastrozole and 3 years no therapy
Arm B: 6 years anastrozole


To assess the disease free survival (DFS) with 6 years of adjuvant anastrozole compared with the current standard treatment of 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of adjuvant tamoxifen treatment.


Primary endpoint:

  • Disease Free Survival

Secondary endpoints:

  • Incidence contralateral breast cancer
  • Overall survival
  • Toxicity
  • Cost effectiveness
Main eligibility criteria:
  • N0 high risk or N+
  • postmenopausal ER/PR+ 
  • 2-3 yrs adj Tamoxifen
  • No locoregional relapse or metastasis
  • CT and/orf RT before/after surgery is allowed
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