Studieoverzicht - 2006-01 DATA

Number 2006-01 DATA
Nickname DATA
Status Closed Date: 07-03-2022
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 1912 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 Maastricht UMC+
Principal Investigator(s) Prof. Dr. Vivianne C.G. Tjan-Heijnen
Study manager
Central datamanagement and randomization Central Datamanagement:
Tel 088 234 6500
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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