|
Current European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Group (BCG) trials |
||||
| Trial number |
Study title |
Start date |
Required number of patients |
Total randomised/registered on 1 April 2004 |
|
|
||||
| 10981-22023 |
AMAROS study – After Mapping of the Axilla: Radiotherapy or Surgery |
15 February 2001 |
3485 |
1133 |
| 10994 |
p53 study – first prospective intergroup translational research trial assessing the potential predictive value of p53 using a functional assay in yeast in patients with locally advanced/inflammatory or large operable breast cancer prospectively randomised to a taxane regimen versus a nontaxane regimen (BIG number 00-01) |
14 March 2001 |
1440 |
863 |
| 10995-16999 |
A randomised phase II study of CMF in combination with anti-cerbB2 antibody (Herceptin®) in women with metastatic cancer |
5 February 2002 |
66 |
32 |
| 10001-160010 |
A randomised phase II trial evaluating the efficacy of capecitabine and vinorelbine in anthracycline and taxane pretreated metastatic breast cancer |
17 September 2002 |
72 |
38 |
| 10002 |
A survey of the BIG (BIG 03-98) to assess the attitude toward the risk of loss of fertility related to adjuvant therapies for patients with early breast cancer aged younger than 35 years |
5 May 2003 |
385 |
51 |
| 10011 |
HERA study – a randomised three-arm multicentre comparison of 1 year and 2 years of Herceptin®, versus no Herceptin® in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy (BIG 01-01/EORTC 10011) |
BIG, December 2001; EORTC, March 2002 |
4482 |
EORTC BCG, 143; total, 3555 |
| 10021 |
An EORTC randomised, double-blind, placebo-controlled, phase II multicentre trial of anastrozole (Arimidex) in combination with ZD1839 (Iressa) or placebo in patients with advanced breast cancer |
28 May 2003 |
108 |
2 |
| 10031 |
SOFT trial – intergroup study IBCSG 24 02/BIG 2-02/EORTC 10031. A phase III trial evaluating the role of ovarian function suppression and the role of exemestane as adjuvant therapies for premenopausal women with endocrine-responsive breast cancer tamoxifen versus ovarian function suppression + tamoxifen versus ovarian function suppression + exemestane |
14 January 2004 |
3000 |
EORTC BCG, 0; total, 21 |
|
BIG, Breast International Group; CMF, cyclophosphamide methotrexate and 5-fluorouracil; HERA, HERceptin® adjuvant; SOFT, Suppression of Ovarian Function Trial; IBCSG, International Breast Cancer Study Group. | ||||
Rutgers et al. Breast Cancer Res 2004 6:165 doi:10.1186/bcr906 |
||||