First International Registry of Patients with Early Stage Breast Cancer Launched
First International Registry of Patients with Early Stage Breast Cancer Launched Data will enable physicians to examine real-world practice and optimize treatment choices for patients with early stage breast cancer Paris, France - December 7, 2004 - Aventis, part of the sanofi-aventis Group, announced today the launch of A Breast Cancer Registry of Adjuvant STrategies (ABREAST), the first international prospective registry of patients with early stage breast cancer. ABREAST will provide a current picture of `real-life' clinical practice as well as patient and disease characteristics. This registry, using standard patient selection criteria, data collection instruments and definitions will collect data on the treatment and outcome of 36,000 women and men, aged 18 or older, and will provide an understanding of existing and evolving practice patterns. The ABREAST project will include randomly selected 1000 centers in over 60 countries including academic medical centers, community-based facilities and physicians' offices. Analyses of ABREAST data should reveal factors that influence treatment decisions, highlight clinical practice areas requiring education and provide supporting data and resources to include regional considerations in guidelines. "ABREAST will provide physicians with detailed, real-world data from approximately 36,000 patients that may be more representative than information collected in controlled studies and provide insight into treatments and outcomes of patients with early stage breast cancer," said Joyce O'Shaughnessy, MD, Baylor Sammons Cancer Center, Texas Oncology, PA, US Oncology, Dallas, TX, one of five breast cancer experts on the ABREAST scientific committee. "Data from ABREAST will be the first step in establishing a global database to assess current standards of care in early stage breast cancer such as surgery, chemotherapy, hormone therapy and radiation. It is our intent to disseminate this information to provide insight that will help physicians evaluate their treatment choices for their breast cancer patients in early stages." All patients enrolled in the ABREAST project must be diagnosed with stage I or II breast cancer. Patients who are entered into ABREAST will be followed for five years. ABREAST will capture disease characteristics, including tumor size and nodal status, as well as biomarkers, such as hormone receptor status. The registry also will collect information on whether patients are offered and if they pursue subsequent adjuvant or neoadjuvant treatments, such as chemotherapy, hormone or radiotherapy, which have proven survival benefits for patients at risk for cancer recurrence. "Breast cancer is most likely to be cured when it is detected early, and as screening programs expand around the world, more patients will be diagnosed earlier. The rich database created by ABREAST will be an invaluable resource for the global breast cancer community because currently, limited data exist on the treatment and outcomes of patients with stage I-II breast cancer in both industrialized and economically emerging countries", said Joyce O'Shaughnessy, MD, Baylor Sammons Cancer Center, Texas Oncology, PA and US Oncology, Dallas, TX, and member of the ABREAST scientific committee. She also noted that ABREAST investigators intend to present analytical findings of the data at major scientific congresses as well as in peer-reviewed scientific journals. Breast cancer is the most common cancer among women worldwide, and is the second most common after lung cancer for both genders, according to the World Health Organization (WHO). It is found mostly in women but men are also at risk. More than 1,000,000 new cases of breast cancer are reported worldwide annually and more than 400,000 women die each year from the disease. ABREAST is sponsored by sanofi-aventis. About sanofi-aventis The sanofi-aventis Group is the world's 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY). Forward Looking Statement This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by Sanofi-aventis and Aventis, including those listed under "Forward-Looking Statements" and "Risk Factors" in sanofi-aventis's annual report on Form 20-F for the year ended December 31, 2003 and those listed under "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" in Aventis's annual report on Form 20-F for the year ended December 31, 2003. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements. ------------------------------------------------------------ Ytterligere informasjon kan hentes på følgende hjemmeside: http://www.waymaker.no Nedenstående filer kan lastes ned: http://wpy.waymaker.net/client/waymaker1/WOLReleaseFile.aspx?id=56120&fn=wkr0001.pdf Pressemelding i pdf format