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Table 1 Current European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Group (BCG) trials

From: Clinical trials update of the European Organization for Research and Treatment of Cancer Breast Cancer Group

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
  1. 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.