All information about you and your participation in the SOLE study will be used and stored according to the requirements of the Privacy Laws of Australia or New Zealand. Your personal information will be accessed, used and stored in accordance with Commonwealth Privacy Laws and the NSW Health Records and Information Privacy Act 2002. Once studies have been completed, records will be retained in a locked storage facility for a prolonged period (over 15 years). Only staff involved with the study will have access to the information. Data from your participation in the study and test results will be kept by the Australian coordinating centre, the ANZBCTG, and be made available to the international body conducting the trial, the IBCSG. These records will be potentially identifiable and kept securely.
If you wish to withdraw from the study and do not want data relating to you personally to be stored, then the data already collected about your health will be "de-identified". That is, it cannot be linked to you in any way. Any request about your study data should be made in writing to the ANZBCTG Office through your doctor.
If you consent to take part in the research, your medical records may be inspected by the organisation sponsoring the research for purposes of analysing the results. These records may also be looked at by an independent auditing body and regulatory authorities to check that the study is being carried out correctly. Representatives from the ethics committee may also wish to review some of the data. Your name, however, will not be disclosed outside your local centre.
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Hormonal therapy is endocrine therapy used for the treatment of hormone-sensitive breast cancer. It is given to patients in tablet form and includes medications such as tamoxifen (eg Nolvadex®), letrozole (eg Femara®), anastrozole (eg Arimidex®) and exemestane (Aromasin®).
