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IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form 4/05 A Randomized Trial of Adjuvant Chemotherapy with Standard Regimens, Cyclophosphamide, Methotrexate, and Fluorouracil – (CMF) or Doxorubicin and Cyclophosphamide – (AC), Versus Capecitabine in Women 65 Years and Older with Node Positive or Node Negative Breast Cancer What Is a Research Study? This is a clinical trial (a type of research study). Clinical trials include only patients who choose to take part. Please take your time to make your decision. Discuss it with your friends and family. 4/02 You are being asked to take part in this study because you are a woman 65 years of age or older with early stage breast cancer that has been removed by surgery. 4/02 You may be contacted by a Y-ME volunteer to discuss general aspects of this study and this consent document. Medical questions about the treatment of your breast cancer should be directed to the medical staff taking care of you. 4/02 4/02 4/02 11/02 Why Is This Study Being Done? Breast cancer in women your age is a major health issue in the United States. Because very few women 70 years of age and older participate in breast cancer treatment studies, there is a lack of information about the risks and benefits of chemotherapy in this age group. In patients in your age group, adjuvant chemotherapy may be less beneficial because older patients may have more than one serious disease in addition to breast cancer. Your doctor has discussed the risks, benefits and the uncertainties of adjuvant chemotherapy with you and suggests that you consider participating in this clinical trial. Previous studies of metastatic (cancer that had spread to other parts of the body) breast cancer, which included a small percentage of women in your age group, indicated that the response to treatment and tolerability of the side effects were similar in older and younger women. The standard treatment is surgery, followed by adjuvant combination chemotherapy (adjuvant means “in addition” to the surgery) and/or radiation therapy. If your cancer is responsive to hormones, this is then followed by the hormonal therapy (blocks the hormones that are known to stimulate the growth of cancer cells) with the drug tamoxifen, or letrozole or anastrozole for 5 years. Adjuvant combination chemotherapy for women who are less than age 65 with early stage breast cancer is associated with significant improvements in both preventing the cancer from returning and overall survival. It is not known if the same benefits apply to similar women who are age 65 and older. The purpose of this study is to compare the safety and effectiveness of standard adjuvant combination chemotherapy using cyclophosphamide + methotrexate + 5-fluorouracil (CMF), or doxorubicin (also called Adriamycin) + cyclophosphamide (AC), to the chemotherapy drug capecitabine, in women 65 years of age and older. The study will also help gain more information about the effects of each of the treatments on physical and emotional well-being and how well the participants assigned to receive capecitabine follow the treatment plan. 9/15/01 Page 1 of 11 Participant Initials _____ IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form Previous studies in patients with advanced breast cancer have shown that capecitabine has the ability to shrink breast cancer. In previous studies which compared CMF to capecitabine, it appeared that the capecitabine was at least as effective as CMF in shrinking breast cancers. Cyclophosphamide, methotrexate, 5-fluorouracil, and doxorubicin have been approved by the Food and Drug Administration (FDA) of the United States for the treatment of breast cancer. Capecitabine has been approved for the treatment of breast cancer that has spread to other parts of the body and does not respond to other chemotherapy drugs. Its use as adjuvant treatment for early stage breast cancer, as used in this study, is considered to be research. How Many People Will Take Part in the Study? Between 600 and 1,800 women will take part in this study. What Is Involved in the Study? You will be “randomized” into one of the treatment groups described below. Randomization means that you are assigned to a group by chance. The treatment group you are assigned to is chosen by a computer. Neither you nor your doctor will choose which group you will be in. You will have an equal chance of being assigned to either group. R A N D O M I Z E Treatment A CMF or AC Treatment B Capecitabine Treatment A If you are assigned to this treatment group, you and your doctor will decide whether you will receive the CMF or the AC standard combination chemotherapy. These treatments are given as outpatient treatment in the clinic. 4/02 9/05 If you choose CMF, you will be given a prescription for cyclophosphamide tablets, which you will take by mouth, daily for 14 days. You will be asked to record each dose of cyclophosphamide on a Cyclophosphamide Calendar every time your take it. You will be given methotrexate and 5-fluorouracil through a vein over approximately 15-30 minutes on days 1 and 8. This treatment will be repeated every 28 days. This 28 day period is called a treatment cycle. You will receive 6 cycles (6 months) of this treatment. 9/15/01 Page 2 of 11 Participant Initials _____ IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form 9/05 If you choose AC, you will be given doxorubicin and cyclophosphamide through a vein over approximately 15-30 minutes on day 1, every 21 days. This 21 day period is called a treatment cycle. You will receive 4 cycles (3 months) of this treatment. Treatment B If you are assigned to this treatment group you will be given a supply of capecitabine tablets, which you will take at home, by mouth, twice daily for 14 days. This treatment will be repeated every 21 days. This 21 day period is called a treatment cycle. You will receive 6 cycles (4 l/2 months) of this treatment. If you take antacids which contain aluminum hydroxide or magnesium hydroxide (like Maalox®) they should not be taken within one hour of taking the capecitabine. The study staff will give you additional instructions on how to take the capecitabine. 5/15/06 All Treatment Groups After you have completed the study treatment, if your breast cancer is the type that is responsive to hormones your doctor may recomment hormonal therapy with tamoxifen, anastrozole, exemestane or letrozole. If your breast cancer is the type that is responsive to trastuzumab (also known as Herceptin®) your doctor may recommend treatment with this drug. Quality of Life The researchers are also interested in learning if there are differences in the physical and emotional well being of the women who receive Treatment A and Treatment B. Before you are told about your treatment assignment, you will be given a quality of life questionnaire, which you will fill out in the clinic and take home with you. About 2-3 days later a Research Interviewer will contact you by telephone to collect your answers to the questionnaire. This will take about 45 minutes. You will then be interviewed five more times: midway through the study treatment, 1 month after you have completed the study treatment, and at months 12, 18, and 24. These interviews will take about 35 minutes each time. The quality of life questionnaire will be mailed to you before each telephone interview. If you have difficulty hearing and cannot be interviewed by telephone, the questionnaires may be filled out and mailed to the interviewer in addressed, stamped envelopes, which will be sent to you. You will be asked to fill out all of the quality of life questionnaires, even if you do not finish the study treatment. Capecitabine Adherence Consistently following a medication schedule (known as drug adherence) may have a relationship to the effectiveness of the medication. With the availability of more chemotherapy drugs given by mouth, which patients can take themselves, it will be important for doctors to understand any difficulties patients may have in following their medication schedules. 9/15/01 Page 3 of 11 Participant Initials _____ IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form If you are assigned to receive capecitabine, and have agreed to participate in the quality of life interviews, you will be asked to participate in the drug adherence portion of this study. If you agree to participate, the capecitabine tablets will be given to you in special bottles with an electronic device in the lid. The device will record the time that you open and close the bottle. For this reason, we ask that you do not put the tablets into any other bottle and that you do not open the capecitabine bottle unless you are taking a tablet. Also, you should always replace the lid back on the bottle after each time you open it. If you agree to participate you will be given detailed instructions on how to use the special medication containers. If you use a daily pill organizer you can still participate in the adherence portion of this study. Please ask the study team for details. I agree to participate in the quality of life telephone interviews. If I am assigned to receive capecitabine, I also agree to participate in the adherence portion of this study. _____ Yes _____ No _____ Initials Testing and Follow-up If you take part in this study, you will have the following routine tests and procedures before the study treatment begins: you will be asked to give your medical history and have a physical examination, blood tests, a chest x-ray, and a mammogram. If you are going to receive the AC treatment, you will have a MUGA scan or an echocardiogram, which measure your heart’s ability to pump. During the time that you are receiving the study treatment, a physical examination and blood tests will be done on day 1 of each treatment cycle. If you are receiving the CMF treatment, blood tests will also be done on day 8 of each cycle. MUGA scans or echocardiograms will be done, as your doctor feels necessary. After the study treatment has been completed, the physical examinations will be done every 6 months for 2 years, then annually thereafter. The blood tests and mammograms will be done annually. How Long Will I Be in the Study? We think you will receive study treatment for 3 to 6 months, depending on which treatment group you are assigned to. After the treatment has been completed your doctor will follow your medical condition for up to 15 years to learn about the long-term effects of the study. Your doctor will discontinue the study treatment if: the breast cancer returns in the breast or an area outside the breast; you experience intolerable side effects; you and your doctor decide that it is in your best interest to stop; or if new information become available which suggests that the study treatment is unsafe or not effective for you. 9/15/01 Page 4 of 11 Participant Initials _____ IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to your doctor first. What Are the Risks of the Study? While on the study, you will be at risk for these side effects. You should discuss these with your doctor and the study staff. There may also be other side effects that we cannot predict or are unforeseen or unexpected. Other drugs will be given to make the side effects less serious and uncomfortable. Many side effects go away shortly after the study drugs are stopped, but in some cases side effects can be serious, long lasting or permanent. Cyclophosphamide + Methotrexate + 5-Fluorouracil (CMF) Likely • Temporary lowering of the number of white blood cells (cells that help your body fight infection) • Nausea, vomiting or diarrhea • Abdominal discomfort • Loss of appetite • Loss of scalp and body hair • Skin and nail discoloration • Sores in the mouth and/or throat • Irritation of the bladder (where urine is stored) • Skin rash • Hand and foot syndrome (the palms of the hands or soles of the feet tingle, become numb, painful, swollen or red) • Increased sensitivity to sunlight Less Likely, But Serious • Temporary lowering of the number of red blood cells (may cause a feeling of tiredness, and shortness of breath) • Temporary lowering of the number of blood platelet cells (cells that help your blood clot) • Blood in the urine • Irregular heart beat (may occur right after the drugs are given) • Weakened kidney function • Eye irritation • Nasal congestion Doxorubicin + Cyclophosphamide (AC) Likely • Temporary lowering of the number of white blood cells (cells that help your body fight infection) • Temporary lowering of the number of red blood cells (may cause a feeling of tiredness and shortness of breath) 9/15/01 Page 5 of 11 Participant Initials _____ IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form • Temporary lowering of the number of blood platelet cells (cells that help your blood clot) • Nausea, vomiting or diarrhea • Loss of scalp and body hair • Skin and nail discoloration • Sores in the mouth and/or throat • Urine may turn red for 1-2 days (due to the color of the doxorubicin) • Irritation of the bladder (where urine is stored) • Sensitivity to sunlight Less Likely, But Serious • Blood in the urine • Heart damage • Irregular heart beat (may occur right after the drugs are given) • Congestive heart failure (a decrease in the heart’s ability to pump effectively, which may lead to shortness of breath) • Skin tissue damage if some of the drug leaks from the vein while it is being given • Acute leukemia Capecitabine 10/03 Likely • Diarrhea • Nausea and vomiting • Sores in the mouth and/or throat • Abdominal pain • Constipation • Hand and foot syndrome (the palms of the hands or soles of the feet tingle, become numb, painful, swollen or red) Less Likely, But Serious • Temporary lowering of the number of white blood cells (cells that help your body fight infection) • Temporary lowering of the number of red blood cells (may cause a feeling of tiredness and shortness of breath) • Temporary lowering of the number of blood platelet cells (cells that help your blood clot) • Dizziness • Headache • Insomnia (difficulty sleeping) • Loss or decrease of appetite • Eye irritation • Muscle aches • Edema (fluid retention, which can cause swelling of the body) • Problems with liver function (as seen on a blood test) 9/15/01 Page 6 of 11 Participant Initials _____ IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form 10/03 In some individuals, the side effects associated with chemotherapy may be severe or lifethreatening. You will be asked to contact your doctor immediately if you have: Diarrhea: if you have more than 3 bowel movements in one day or diarrhea at night Mouth sores: if you have pain, redness, swelling or sores in your mouth Pain or swelling of the hands or feet: if you have pain, swelling or redness of your hands or feet that prevents normal activity Fever or infection: if you have a temperature of 100.0oF or higher, or other signs of infection 10/15/01 There are many medications (prescription and non-prescription), which may interact with capecitabine. Your doctor will review all of the medications you are currently taking before your participation on this treatment study. You should not take any new medications without discussing it with your doctor first. If you are taking blood thinners such as warfarin (Coumadin®) or phenytoin (Dilantin®), your doctor will need to monitor these medications while your are taking capecitabine. 10/03 Reproductive Risks (Pregnancy/Birth Control): Due to the unknown risks and potential harm to the unborn fetus, sexually active women of childbearing potential must use a reliable method of birth control while participating in this study. Reliable methods of birth control are considered to be: abstinence (not having sex), tubal ligation or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge. We encourage you to discuss this issue further with your doctors if you have any questions. A woman should not nurse her baby while on this study. Ask about counseling and more information about preventing pregnancy. Pregnant women and nursing mothers are excluded from participation in this study. If a woman becomes pregnant, she will be withdrawn from the study. Since most methods of birth control are not 100% reliable, if you are a sexually active woman of childbearing potential, a pregnancy test (at least 10 days from your last normal menstrual period) is required. For more information about risks and side effects, ask your doctor or contact your researcher. Will I Benefit From Taking Part in the Study? If you agree to take part in this study, there may or may not be direct medical benefit to you. We hope the information learned from this study will benefit other patients with breast cancer in the future. The possible benefits of taking part in the study may be the same as receiving standard CMF or AC treatment without being in the study. Although capecitabine is known to be effective in women with metastatic breast cancer, this study will help the researchers learn if capecitabine is as effective as standard adjuvant chemotherapy in older women with early stage breast cancer. 9/15/01 Page 7 of 11 Participant Initials _____ IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form What Other Options Are Available? You do not have to participate in this study to receive treatment for your breast cancer. Standard treatment for your type of breast cancer can include surgery, chemotherapy, radiation therapy, and tamoxifen. You do not have to participate in this study to receive adjuvant CMF or AC chemotherapy. Please talk to your doctor about these and other options. What About Confidentiality? Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. A record of your progress will be kept in a confidential form at your hospital or doctor’s office where you receive treatment. Organizations that may inspect and/or copy your research and medical records (blood samples, x-rays, scans, pathology slides, etc.) for quality assurance and data analysis include groups such as: Southeast Cancer Control Consortium (SCCC) Operations Office Cancer and Leukemia Group B (CALGB) National Cancer Institute (NCI) Food and Drug Administration (FDA) Office for Human Research Protections (OHRP) Institutional Review Board (IRB) at your hospital A qualified representative of Roche Laboratories, Inc., the drug manufacturer of capecitabine Possible other federal or state government agencies Y-ME, a patient support organization, will be provided with your name solely for the purpose of evaluating an educational program related to this study. If your record is used or given out for governmental purposes, it will be done under conditions that will protect your privacy to the fullest extent possible consistent with laws relating to public disclosure of information and law-enforcement responsibilities of the agency. You authorize the use of clinical information contained in your records, but any publication which includes such information or data shall not reveal your name, show your picture or contain any other personally identifying information, except as otherwise required by law. What Are The Costs? Taking part in this study may lead to added costs to you or your insurance company. You or your insurance carrier will be responsible for the costs of clinic visits, any hospital admissions, laboratory tests, x-rays, scans, chemotherapy treatments, and any other tests. Please ask your doctor about any added costs or insurance problems. You will not be paid to participate in this study. 9/15/01 Page 8 of 11 Participant Initials _____ IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form In the case of injury or illness resulting from this study, emergency medical treatment is available but will be provided at the usual charge. No funds or monies have been set aside to compensate you in the event of injury. You or your insurance company will be charged for continuing medical care and/or hospitalization. The study drug capecitabine (Xeloda) will be provided free of charge to your doctor by Roche Laboratories, Inc., through the Division of Cancer Treatment and Diagnosis of the National Cancer Institute (NCI). However, if the manufacturer of this drug should discontinue to supply it for this study, you may be required to purchase subsequent doses. You and/or your insurance company will be responsible for all other costs of the study treatment. What Are My Rights As A Participant? Taking part in this study is voluntary. You may choose not to take part or you may leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled. If you withdraw from the study, you will continue to be followed and clinical data will be collected from your medical records as long as we have your consent. You are free to seek care from a doctor of your choice at any time. A Data and Safety Monitoring Board, an independent group of experts, will be reviewing the data from this research throughout the study. We will tell you about the new information from this or other studies that may affect your health, welfare or willingness to stay in this study. Who Do I Call If I Have Questions Or Problems? For questions about the study or a research-related injury, contact your doctor, ____________, at # _____________________. You may ask your doctor for further information on the risks, benefits or alternative treatments. For questions about your rights as a research participant, contact the ___________________ Institutional Review Board (which is a group of people at the hospital in the community where you receive treatment who review the research to protect your rights) at # __________(the office of ____________________). Related studies The researchers are also interested in learning more about breast cancer in older women, such as the possibility of predicting response to cancer treatment, survival after treatment, and to learn if there are differences between older and younger women. These research studies will measure levels of certain enzymes and proteins called “tumor markers”, which are found in cancer tissue. These research studies will not involve the study of cancer genes that can be inherited (passed from parents to children). The results of these research studies will not be given to you or your doctor, nor will the results have any effect on your treatment. 9/15/01 Page 9 of 11 Participant Initials _____ IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form If you agree a sample of your breast cancer tissue, which was taken at the time of diagnosis for routine testing, will be sent to a CALGB research laboratory where it will be used for these studies. It is not possible for you or the CALGB to know what studies of breast cancer may be appropriate in the future. So we ask that you give permission in advance for other studies related to breast cancer without being re-contacted for each test. The research that may be done with your breast cancer tissue samples probably will not help you. It might help people in the future who have breast cancer. In addition, some of this tissue may be used to establish products that could be patented and licensed. There are no plans to provide financial compensation to you should this occur. There will be no charge to you for participating in these research studies. If you decide now to allow your tissue sample to be used in these and future studies and then change your mind at any time about participating in the studies, just contact your institution and let them know that you do not want the researchers to use your sample. Then it will no longer be used for research. The results from these studies may be published, but individual patients will not be identified in these publications. Your participation in these research studies is entirely voluntary. You do not have to participate in this portion of the study to receive the study treatment. I agree to the use of my specimen for research and teaching purposes related to my cancer, including the specific studies described above. _____ Yes _____ No Initials _____ I agree to be contacted in the future to discuss whether I will give permission for my specimen to be used for genetic research. _____ Yes _____ No Initials _____ I agree to allow my specimen to be used for research unrelated to my cancer. _____ Yes _____ No 9/15/01 Initials _____ Page 10 of 11 Participant Initials ____ IRB Approval Date ____________ Version: Update #14 5/15/06 CALGB 49907 Southeast Cancer Control Consortium Consent Form 4/02 Where Can I Get More Information? You may call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) or TTY: 1-800-332-8615 or you may visit the Cancer Information Service Website: http://www.cancer.gov/cis You may visit the NCI’s Web site: http://www.cancer.gov This website contains comprehensive clinical trials information and accurate cancer information. Participant Contract I have been offered the opportunity to ask questions about this study and all questions have been answered to my satisfaction. The contents of this form have been explained to me and I understand them. I agree to allow the research personnel specified above the access to my medical records. It may be necessary for my doctor to contact me at a future date regarding new information about the treatment I received, therefore I agree to notify my doctor of any change of address and/or telephone number. 10/15/04 My signature below means that I have voluntarily agreed to participate in this research study. I will be given a copy of all 11 pages of this consent. I may also request a copy of the study (complete study plan). ______________ (Date) _________________________________ (Participant Signature) I certify that I have explained to the above individual the nature and purpose, the potential benefits, and possible risks associated with participation in the research study and have answered any questions that have been raised. ______________ (Date) 9/15/01 _________________________________ (Signature of Person Obtaining Consent) Page 11 of 11 CALGB 49907 Southeast Cancer Control Consortium Withdrawal of Treatment Consent I, _____________________________, withdraw my consent for treatment on CALGB 49907. Even though I withdraw my consent for treatment, I will continue to be followed and clinical data will be collected from my medical records. Participant Name __________________________ CALGB ID Number _____________ (Please Print Name) Participant Signature _________________________________ Date _______________ Witness Signature ___________________________________ Date _______________ 9/15/01 CALGB 49907 Southeast Cancer Control Consortium Withdrawal of Consent I, __________________________, withdraw my consent to participate in CALGB 49907 and refuse to be followed and have clinical data collected from my medical records. Participant Name __________________________ CALGB ID Number _______________ (Please Print Name) Participant Signature _________________________________ Date _______________ Witness Signature ___________________________________ Date _______________ 9/15/01 CALGB 49907 Southeast Cancer Control Consortium Consent Form CALGB 49907 Y-ME TELEPHONE CONTACT PROGRAM Because you have said that you are undecided about whether or not your want to participate in this clinical trial (research study) that your doctor and/or the medical staff have already discussed with you, we would like to offer you the opportunity to speak with a Y-ME volunteer. Sometimes women who are making decisions about their cancer treatment find it helpful to speak with someone who has previously received treatment for cancer. The Y-ME National Breast Cancer Organization has a special program to provide telephone contact from a breast cancer survivor. Through this program women in your age group from the Y-ME organization who have received chemotherapy for breast cancer are available to provide information about the clinical trial and to discuss their experiences during breast cancer treatment. If you agree to be contacted, your doctor will forward your name and telephone number to the Y-ME National Breast Cancer Organization. A few days later, a breast cancer counselor from Y-ME will contact you over the phone. During the telephone call, the Y-ME counselor will provide general information about the clinical trial, the informed consent document, the counselor’s personal experience with participation in a clinical trial, and emotional support. If you wish, the Y-ME counselor can speak with a member of your family, or provide a follow-up call at another date. Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. Your participation in this telephone contact program is voluntary. Refusal will not affect your medical care in any way. By signing below, you indicate that you have read this form and willingly consent to be called. You will receive a copy of this form with the informed consent document for this clinical trial attached. We encourage you to have this document with you at the time of the telephone call. AUTHORIZATION I have read this form and have decided that I will participate in the telephone contact program described above. ______________________________________ (Please Print Participant Name) ______________________________________ (Participant Signature) 4/15/02 123 ________________________ (Date)