Table 1 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 |