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 | |||||
Website | http://www.boogstudycenter.nl | ||||
Sponsor | Maastricht UMC+ |
Principal Investigator(s) | Prof. Dr. Vivianne C.G. Tjan-Heijnen | |||
Study manager | ||||
Central datamanagement and randomization | Central Datamanagement: IKNL trialbureau@iknl.nl / a.swinkels@iknl.nl Tel 088 234 6500 |
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Monitoring | AstraZeneca | |||
Local datamanagement | ||||
Funding | ||||
Extra |
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
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
Documents (public):
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