Studieoverzicht - 2006-04b TEAM IIb

 
Number 2006-04b TEAM IIb
Nickname TEAM IIb
Status Closed 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
E-mail datacenter@lumc.nl
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):

Protocol synopsis

Documents (protected):
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