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 | ||||
| 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):
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