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DATA

  • Closed

BOOG 2006-01

General Information

BOOG number

BOOG 2006-01

Nickname

DATA

Status

  • Closed
Date: 07/03/2022

Other study number

D5392-NL-003

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.

Indication

  • Adjuvant

Subindication

Any HER2, HR+

Target sample size

1900-01-01

Actual accrual

1912-01-01
Date: 04/08/2009

Estimated study completion date

01/09/2009

Contact

Sponsor

Maastricht UMC+

Principal Investigator(s)

Prof. Dr. Vivianne C.G. Tjan-Heijnen

Central datamanagement and randomization

Central Datamanagement: IKNL trialbureau@iknl.nl / a.swinkels@iknl.nl Tel 088 234 6500

Monitoring

AstraZeneca

Design

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

Objectives

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.

Endpoints

Primary endpoint:

  • Disease Free Survival

Secondary endpoints:

  • Incidence contralateral breast cancer
  • Overall survival
  • Toxicity
  • Cost effectiveness

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

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 12/04/2006
Nr:2006/023

EC

CMO Regio Arnhem-Nijmegen
Amendments:
Yes
Date Last Amendment: 12/04/2007

EudraCT number

2005-006167-31

Trial Register

NCT00301457

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