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 ClinicalResearchCenter@lumc.nl E-mail datacenter@lumc.nl |
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Monitoring | ||||
Local datamanagement | ||||
Funding | ||||
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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):
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