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IRB Approval ______________ NSABP B-40 Southeast Cancer Control Consortium Consent Form Addendum #1 A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens [This information was not provided in the original consent form that patients signed. It is provided here as new information to be given to patients after local approval of Amendment #2.] When you joined the NSABP B-40 study, the NSABP promised to tell you about new information that might affect your participation in the trial. The NSABP would like to inform you of some changes to the study and some additional side effects related to the drugs used in this study. New information about side effects related to bevacizumab: You were told in the original consent form you signed that the drug bevacizumab may cause wound healing problems for patients who undergo surgery while receiving the drug. There have also been a few reports of patients receiving bevacizumab in other trials who developed complications with wound healing due to skin problems such as leg ulcers. These wound healing problems have been associated with infections that may take a long time to heal. Therefore, if you develop any skin problems, such as open sores or wounds, tell your study doctor. You were also told in the original consent form you signed that some patients with cancer in the abdomen or pelvis have developed bowel perforations while receiving bevacizumab. (A bowel perforation is an abnormal opening in the bowel wall allowing bowel contents to spill into the abdomen.) The company that makes bevacizumab recently reported that patients receiving bevacizumab for cancers that are not in the abdomen and pelvis have also had bowel perforations. In a small study for patients with advanced lung cancer, 3 out of 17 patients who were receiving the combination of docetaxel, gemcitabine, and bevacizumab developed bowel perforations that resulted in death. Because of these deaths, the study was stopped. Bowel perforations have not been reported in patients receiving this same drug combination in 2 other studies, so it is not clear whether the bowel perforations that occurred in the lung cancer patients were related to this combination of drugs or to other medical conditions. Since you signed the original consent form, there have also been reports of patients receiving bevacizumab who experienced the following side effects: 2/15/08 Page 1 of 3 Participant Initials _____ IRB Approval ______________ NSABP B-40 Southeast Cancer Control Consortium Consent Form Addendum #1 In addition to bowel perforation, perforation of other organs or tissues (rare, occurring in less than 3% of patients receiving bevacizumab). Fistula (an abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected) may occur, for example, between the gastrointestinal tract and the skin or between the gastrointestinal tract and the vagina. A rare type of fistula, tracheo-esophageal fistula, which is an abnormal connection between the windpipe (trachea) and the esophagus (the tube that connects the mouth to the stomach) has been reported. (rare, occurring in less than 3% of patients receiving bevacizumab) High blood pressure of the blood vessels in the lungs (rare, occurring in less than 3% of patients receiving bevacizumab). Low red blood cell count (may lead to anemia, tiredness, shortness of breath); (less likely, occurring in 3-9% of patients receiving bevacizumab). Allergy type symptoms like stuffy nose and sneezing (less likely, occurring in 3-9% of patients receiving bevacizumab). Abnormally slow bowel contraction (less likely, occurring in 3-9% of patients receiving bevacizumab) Bleeding from the lining of the vagina (less likely, occurring in 3-9% of patients receiving bevacizumab) Information about side effects related to gemcitabine and docetaxel: You were told in the original consent form you signed that the drug docetaxel alone and the combination of capecitabine and docetaxel may cause the side effects listed below. However, these risks were accidentally not included in the list of risks related to the combination of gemcitabine and docetaxel. Thus, the NSABP would like to inform you that the risks listed below are also related to the combination of gemcitabine and docetaxel. Peeling of the skin (including hands and feet); (less likely, occurring in 3-9% of patients receiving gemcitabine and docetaxel) Blurred vision (less likely, occurring in 3-9% of patients receiving gemcitabine and docetaxel) Heart damage (rare, occurring in less than 3% of patients receiving gemcitabine and docetaxel) Gastrointestinal problems (such as bleeding, blockage, or perforation which is an abnormal opening in the stomach or bowel); (rare, occurring in less than 3% of patients receiving gemcitabine and docetaxel) Information about required tissue collection following your surgery: You were told in the original consent form you signed that small samples of the tissue removed during your surgery would be sent to the NSABP. They now will only receive 2/15/08 Page 2 of 3 Participant Initials _____ IRB Approval ______________ NSABP B-40 Southeast Cancer Control Consortium Consent Form Addendum #1 samples if any tumor remaining at the time of your surgery is 1 cm (about half an inch) or larger. Information about breast reconstruction: You were told in the original consent form you signed that if you were randomized to Group 1B, 2B, or 3B and you have a mastectomy, that you would not be able to have breast reconstruction until at least 3 months after your bevacizumab is completed. If you have not yet had your mastectomy, you may have breast reconstruction at the same time as your mastectomy. However, if tissue expanders are used, the expander may only be expanded slightly and only up until 2 weeks before you resume bevacizumab. No further expansion will be performed until after you complete your bevacizumab therapy. If you have questions about any of this information, you should discuss them with your study doctor _______________________ at phone # ________________________. Signatures I have been given this new information that was not in the original consent form. _____________________ Date Date 2/15/08 _______________________ Participant Signature Signature of person conducting the informed consent discussion Page 3 of 3