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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