Studieoverzicht - 2006-04a TEAM IIa

 
Number 2006-04a TEAM IIa
Nickname TEAM IIa
Status Closed Date: 29-05-2012
Inclusion closed
Other study number(s)
Participating parties/groups
Full title Multicentre, prospective phase II trial investigating the efficacy of neoadjuvant hormonal therapy with exemestane for six months
Phase and type Prospective Phase II
Age ≥18
Menopausal status Postmenopausal
Indication Neoadjuvant
Subindication Any HER2, HR+
Target sample size 100
Actual accrual 107 Date: 01-06-2012
Estimated study completion date 31-12-2011
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 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
E-mail datacenter@lumc.nl
Monitoring
Local datamanagement
Funding
Extra

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.
Main 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
Documents (public):

Protocol synopsis

Documents (protected):
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