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Announcement
ANNOUNCEMENT
Pivotal is pleased to announce that the European Medicines Agency (EMA) has recently approved a new indication for docetaxel (Taxotere®) in the node negative setting for Breast Cancer patients in combination therapy. This approval was based on the data from a Clinical Trial entitled “A multicenter phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus 5-Fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of high risk operable breast cancer patients with negative axillary lymph nodes (TAX.ES1.301).”
The trial was managed entirely by Pivotal with regards to monitoring, project management, medical support, data management and biostatistics. The trial enrolled 1060 patients in three countries (Spain 962 patients in 49 participating sites, Germany 56 patients in 7 participating sites and Poland 42 patients in 2 participating sites) during 3 years who were followed up for efficacy a median of 6.4 years. The results supported the said indication. The trial is the first joint collaboration among a Pharmaceutical Company (Sanofi Aventis), a Cooperative Group (GEICAM) and a CRO (Pivotal) which ran in 3 European Countries with a major contribution from Spain and is , as far as we know, the first mainly Spanish Phase III mega-trial which serves as the basis for the approval of an indication at the EMA level. It´s also an innovative trial since it is the first trial performed exclusively in Node Negative Breast Cancer patients, the result of which is a landmark for the treatment of these patients.
We are grateful to all those who have made this endeavour possible and above all to the enrolled patients.
Pivotal Management Team
May 2010
