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TEAM IIb

  • Follow up

BOOG 2006-04b

General Information

BOOG number

BOOG 2006-04b

Nickname

TEAM IIb

Status

  • Follow up
Date: 27/05/2014

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.

Indication

  • Adjuvant

Subindication

Any HER2, HR+

Target sample size

1116

Actual accrual

1116
Date: 27/05/2014

Estimated study completion date

31/12/2013

Contact

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
Datacenter@lumc.nl

Design

Randomization: Arm A: hormonal treatment with oral ibandronate (50 mg once daily) for three years Arm B:hormonal treatmentwithoutoral 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.

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

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 07/08/2006

EC

Nederlands Kanker Instituut
Amendments:
Yes
Date Last Amendment: 26/08/2009

EudraCT number

2006-005105-55

Trial Register

ISRCTN17633610

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