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About Participation in this Clinical Research Study If you are eligible and wish to take part in this clinical research study, you will have a study-related physical exam, along with other screening tests that include blood samples, an EKG (electrocardiogram), a chest X-ray, and a tumor assessment. The investigational drug, and all medical care and tumor assessments required solely for the research study, will be provided by the study sponsor. The costs of the standard medications, tests, and procedures will be billed to you and/or your insurance company. At the start of the treatment phase, you will be assigned at random (like flipping a coin) to receive either the investigational drug or a placebo, in addition to standard medications (Herceptin and docetaxel) throughout the clinical trial. Study visits will occur every three weeks. During your visits, study medication will be administered, your health will be monitored, and you will be provided with information and support. You will have tumor assessments every nine weeks. |
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