EORTC 10085 (Male breast project) completed its first part (retrospective) in September 2013 with 1,822 patients registered. It was running in the following countries: the United States of America, Belgium, the United Kingdom, Poland, The Netherlands (BOOG), Ireland (ICORG), Spain, Switzerland (SAKK) and Sweden (SABO), making this a truly international effort. FFPE samples have been centralized in EU and US central labs. Analysis on a first group of biomarkers (ER, AR, PgR, HER’s-2 and Ki67) is already complete and will be followed soon by the histopathology review.
The 1st results have been presented at SABCS 2014 during the general session and will be published soon.
EORTC 10981-22023 (AMAROS) was a phase III study comparing a complete axillary lymph node dissection with radiotherapy to the axilla in sentinel node positive patients. The main objective of the trial was to provide equivalent local/regional control for patients with proven axillary lymph node metastases, as detected by sentinel node biopsy, with reduced morbidity by treating with axillary radiotherapy instead of axillary lymph node dissection. The study completed accrual in April 2010 with 4,828 patients included. Final results have been recently accepted for publication in Lancet Oncology (Lancet Oncol. 2014 Nov;15(12):1303-10).
EORTC 10054 (Lapatax) phase I/II trial was designed to compare the use of Lapatinib, Herceptin and a combination of the two when given in conjunction with Docetaxel during FEC-D neoadjuvant chemotherapy for large operable and locally advanced breast cancer. Results of the Phase I were published in EJC (Eur J Cancer. 2013 Jan;49(2):281-9). The phase II part of the study finished recruitment in January 2013 with 121 patients enrolled. Fourteen centers in five countries participated in the trial. Final results have been recently accepted for publication in Annals of Oncology.
EORTC 10994 (p53) was an intergroup translational research trial. It prospectively randomized 1,856 patients to test the hypothesis that a neo-adjuvant taxane regimen confers a greater advantage over an anthracycline regimen in p53 mutated tumors than in p53 wild type tumors. The final results of this trial were published in Lancet Oncology (Lancet Oncol. 2011 Jun;12(6):527-39). The trial data also contributed to an FDA led meta-analysis on the surrogate value of pathological complete response that was published in the Lancet (Lancet. 2014 Jul 12;384(9938):164-72).