Studieoverzicht - 2001-01 TEAM
| Number | 2001-01 TEAM | ||||
| Nickname | TEAM | ||||
| Status | Closed | Date: 23-01-2006 | |||
| Inclusion closed | |||||
| Other study number(s) | |||||
| Participating parties/groups | |||||
| Full title | Tamoxifen and Exemestane Adjuvant Multicenter Trial An open label, randomized multicenter comparative trial of 5 years adjuvant Exemestane treatment versus Tamoxifen for 2½-3 years followed by 2½-2 years of Exemestane, for a total of 5 years as adjuvant treatment in Postmenopausal Women with Early Breast Cancer | ||||
| Phase and type | Randomized Phase III | ||||
| Age | >18 | ||||
| Menopausal status | Postmenopausal | ||||
| Indication | Adjuvant | ||||
| Subindication | Any HER2, HR+ | ||||
| Target sample size | 8740 | ||||
| Actual accrual | 9875 | Date: 23-01-2006 | |||
| Estimated study completion date | |||||
| CCMO approval | Not applicable | Date: 02-11-2010 | Nr: | ||
| EudraCT nr. | |||||
| Trial Register | ISRCTN75225940 | ||||
| METC approval | Yes | Date: 04-01-2001 | METC: Erasmus Medisch Centrum Rotterdam | Nr: 198.231/2001/7 | |
| Amendments | Yes | Date: 13-12-2004 | |||
| KWF-CKS approval | Date: 02-11-2010 | Nr: | |||
| News item | |||||
| Website | http://boogstudycenter.nl | ||||
| Sponsor | LUMC Heelkunde (NL); Pfizer (intl) | ||||
| Principal Investigator(s) | C.J.H. van de Velde, J.W.R. Nortier, C. Seynaeve, L. Beex | |||
| Study manager | E. Meershoek-Klein Kranenbarg | |||
| Central datamanagement and randomization | Leiden University Medical Center Datacenter Surgery K6-R P.O. Box 9600, 2300 RC Leiden Phone +31 71 526 3500 Fax +31 71 526 6744 |
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| Monitoring | ||||
| Local datamanagement | ||||
| Funding | ||||
| Extra | ||||
Design:
Randomization:
ArmA: exemestane (25 mg once daily) for 5 years
Arm B: tamoxifen (20 mg once daily) for 2½-3 years followed by 2½-2 years of exemestane (25 mg once daily).
Objectives:
To determine whether up- front adjuvant treatment with exemestane compared with adjuvant tamoxifen improves the relapse- free survival (RFS) of postmenopausal, receptor positive, early breast cancer patients following 2¾ (2½ -3) years of treatment.
Endpoints:
Primary endpoint:
- Relapse Free Survival (RFS) at 2¾ years
Secondary Endpoints:
- RFS at 5 years;
- Overall survival (OS); Incidence of second breast cancer (in contralateral breast);
- Safety and long-term tolerability of the regimens
Main eligibility criteria:
- Female
- Postmenopausal
- ER and/or PR+
- T > 3 cm or N+ or T < 3 cm, N0 but MAI >10 or BR grade 3 or adj therapy acccording to Ducth guidelines
Documents (public):
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