Studieoverzicht - 2006-04b TEAM IIb
| Number | 2006-04b TEAM IIb | ||||
| Nickname | TEAM IIb | ||||
| Status | Follow up | Date: 27-05-2014 | |||
| Inclusion closed | |||||
| Other study number(s) | |||||
| Participating parties/groups | |||||
| Full title | Randomised, multicentre, prospective, phase III trial investigating the efficacy and safety of the addition of ibandronate to adjuvant hormonal therapy in postmenopausal women with hormone receptor positive early breast cancer. | ||||
| Phase and type | Randomized Phase III | ||||
| Age | ≥18 | ||||
| Menopausal status | Postmenopausal | ||||
| Indication | Adjuvant | ||||
| Subindication | Any HER2, HR+ | ||||
| Target sample size | 1116 | ||||
| Actual accrual | 1116 | Date: 27-05-2014 | |||
| Estimated study completion date | 31-12-2013 | ||||
| CCMO approval | Not applicable | Date: | Nr: | ||
| EudraCT nr. | 2006-005105-55 | ||||
| Trial Register | ISRCTN17633610 | ||||
| METC approval | Yes | Date: 07-08-2006 | METC: Nederlands Kanker Instituut | Nr: | |
| Amendments | Yes | Date: 26-08-2009 | |||
| KWF-CKS approval | No | Date: | Nr: | ||
| News item | |||||
| Website | http://www.boogstudycenter.nl | ||||
| Sponsor | LUMC-Heelkunde; PI vd Velde | ||||
| Principal Investigator(s) | S.C. Linn, C.J.H. van de Velde, J.W.R. Nortier, V.C.G. Tjan-Heijnen, C.M.J.C. Seynaeve | |||
| 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 ClinicalResearchCenter@lumc.nl E-mail datacenter@lumc.nl |
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| Monitoring | ||||
| Local datamanagement | ||||
| Funding | ||||
| Extra | ||||
Design:
Randomization:
Arm A: hormonal treatment with oral ibandronate (50 mg once daily) for three years
Arm B: hormonal treatment without oral ibandronate
Objectives:
To determine the efficacy, as assessed by disease free survival, and safety, of ibandronate as additional adjuvant therapy in postmenopausal women with hormone receptor positive primary breast cancer and an indication for adjuvant hormonal therapy.
Endpoints:
Primary endpoint:
- Three years disease free survival.
Secondary enpoints:
- Time to and rate of bone metastases as first occurence, in patients treated with these regimens.
- Time to and rate of bone metastases, per se, in patients treated with these regimens.
- Time to and rate of visceral and other distant metastases in patients treated with these regimens.
- Time to and rate of local- and locoregional recurrences in patients treated with these regimens.
- Time to and rate of contralateral breast cancer in patients treated with these regimens.
- Five years disease free survival.
- Overall survival (all cause mortality and breast cancer specific mortality) in patients treated with these regimens.
- Safety and toxicity of ibandronate in patients treated with this bisphosphonate.
- Specific prognostic indicators for the development of bone metastases and factors that are able to predict specific benefit from ibandronate treatment in these patients using tissue micro-array and other modern techniques.
Main eligibility criteria:
- Histological confirmed invasive adenocarcinoma of the breast;
- Stage I-III breast cancer;
- Completed adequate surgical treatment;
- ER expression > 10% and/or PgR > 10%);
- Known HER2 status.
- Postmenopausal women
Documents (public):
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