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TEAM IIa

  • Closed

BOOG 2006-04a

General Information

BOOG number

BOOG 2006-04a

Nickname

TEAM IIa

Status

  • Closed
Date: 29/05/2012

Full title

Multicentre, prospective phase II trial investigating the efficacy of neoadjuvant hormonal therapy with exemestane for six months

Indication

  • Neoadjuvant

Subindication

Any HER2, HR+

Target sample size

100

Actual accrual

107
Date: 01/06/2012

Estimated study completion date

31/12/2011

Contact

Sponsor

LUMC-Heelkunde; PI vd Velde

Principal Investigator(s)

S.C. Linn, C van der 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

Design

Multicentre, prospective, phase II trial with six months of neoadjuvant therapy with exemestane 25 mg once daily.

Objectives

To investigate whether six months of neoadjuvant therapy with exemestane is superior to three months with respect to the rate of downsizing in postmenopausal women with strong ER positive (> 50% of tumour cells positive) primary breast cancer.

Endpoints

Primary enpoint:

  • Objective response rate of the primary breast tumour, assessed by palpation, which is preferably performed by the same person.

Secondary enpoints:

  • Objective response rate of the breast tumour by mammography (RECIST).
  • Objective response rate of the breast tumour assessed by ultrasound (RECIST).
  • Objective response rate of the breast tumour assessed by MRI (RECIST).
  • Objective response rate of the regional lymph nodes assessed by ultrasound (RECIST).
  • Pathological complete response rate of primary breast cancer.
  • Pathological complete response rate of eventually positive lymph nodes.
  • Number of patients who required a mastectomy before neoadjuvant therapy and for whom breast conserving surgery became feasible after neoadjuvant therapy (independent of actual surgical treatment received).
  • Number of patients who required a mastectomy before neoadjuvant therapy and who received breast conserving surgery after neoadjuvant therapy.
  • Determination of predictive factors able to predict clinical and pathological response.
  • Collection of tumour samples for translational research to improve diagnostics and treatment of breast cancer.

Eligibility Criteria

Histologically, by core needle biopsy-proven, invasive adenocarcinoma of the breast ER expression >50% T >= 2 cm (uitzondering cT4d) Indication to receive adjuvant hormonal therapy Postmenopausal

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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