Phase 3 study of Denosumab as adjuvant treatment, early stage breast cancer, high risk of recurrence; D-CARE
What is the purpose of this trial?
The purpose of this research study is to evaluate how safe and effective denosumab is, compared with placebo, in delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence Denosumab has been approved by some countries regulatory agencies for certain uses. However in this current trial denosumab is considered an investigational product, which means that it has not been approved by an appropriate regulatory agency for the condition being studied. We are testing if denosumab, a protein, might stop cancer from getting worse or spreading to bones. Denosumab is given as an injection under the skin. There will be a 1 in 2 (50:50) chance of receiving denosumab or placebo, like flipping a coin. Placebo will be identical to denosumab with the exception of the protein content. Placebo is defined as “an inactive substance or preparation used as a control in an experiment or test to determine the effectiveness of a medicinal drug”. Since this is a blinded study, neither the patient or the doctor and his/her study staff will know which treatment the patient will be receiving. The reason for doing this is to make sure that there is no bias (favoritism) when making any decision about the safety and effectiveness of this investigational product. Treatment information is available if needed for an emergency. The patient will be asked to provide samples of blood and tumor tissue. The samples will be studied to look for special markers that can be used to tailor the use of denosumab in treating the spread of cancer and/or to study that disease. The expected time that the patient will receive treatment on this study is about 60 months or 5 years. The patient will also be followed for an additional about 60 months or 5 years after the patient ends treatment to assess the status of their disease. However, the patients doctor will assess the patients individual response to the blinded treatment and participation may be longer or shorter than the estimated average. The patients doctor or the sponsor may decide to withdraw the patient from treatment for several reasons. These may include taking certain medications, such as bisphosphonates or commercial denosumab, being noncompliant (not following the study procedures as directed by the aptients doctor), or, if the patient or the patients doctor feel it is in the patients best interest to discontinue for any other reason.
- 18 Years and older
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