A GUIDE TO THIS REFLECTIONS B RESEARCH STUDY IF YOU RE FIGHTING BREAST CANCER, YOU RE NOT ALONE

Transcription

1 A GUIDE TO THIS REFLECTIONS B RESEARCH STUDY IF YOU RE FIGHTING BREAST CANCER, YOU RE NOT ALONE

2 Do you have breast cancer that has spread to outside the breast? Has your tumor tested positive for the HER2 receptor? Have you not received treatment since the tumor has spread? What are clinical studies? You may be interested in a clinical research study in patients with HER2-positive metastatic breast cancer (MBC). This brochure will tell you a little about this REFLECTIONS B study, as well as clinical studies in general. If you have any questions, or would like to discuss the study further, please contact the study site staff using the details provided on the back cover of this brochure. Clinical studies involve research of investigational drugs in people who volunteer to participate in them. All medications are investigated in a number of carefully controlled and highly regulated clinical studies that are designed to answer questions about the safety and benefits of an investigational medication. Every clinical study must be reviewed by the regulatory authorities and independent ethics committees in all countries that the study will be conducted in prior to the study being started. Physicians and their research staff oversee these studies. Choosing to take part in a clinical trial is an important personal decision. By answering specific questions, clinical studies help us find alternative medicines to current options. Thousands of people all around the world take part in clinical studies every year. Every volunteer is important because without these individuals, the development of medicines simply would not be possible. Why is this REFLECTIONS B study necessary? A number of different medicines are available for the treatment of HER2-positive breast cancer. One such treatment is called Herceptin (trastuzumab), which has shown to be effective in patients with HER2- positive breast cancer in the early stage and also after it has spread. Trastuzumab is a biologic drug that has a large and complicated structure. A biosimilar is a drug that has a structure that is highly similar to the original drug and has been shown to have a similar benefit and safety profile to the original drug. We are developing an investigational drug that has a structure that is similar to trastuzumab and is now being tested in clinical trials. This REFLECTIONS B study is being conducted as part of a larger research program to develop a potential biosimilar for trastuzumab for individuals with HER2-positive breast cancer. The REFLECTIONS B study will evaluate whether the investigational drug has a similar benefit and safety profile compared to the known profile for trastuzumab. Who can take part in this REFLECTIONS B study? We are looking for female patients with HER2-positive metastatic breast cancer to take part in this REFLECTIONS B study. In particular, eligible patients must: Have breast cancer that has spread to outside the breast Have a tumor that tested positive for the HER2 receptor Not received treatment since the tumor has spread There are some additional medical criteria that must be met to join the study. Before joining, all patients would need to have a number of screening tests to make sure the study is suitable for them.

3 What study Drug would I get? If you are eligible and choose to join this REFLECTIONS B study, you will be assigned to one of two study groups. To make sure the study is completely fair, the study group to which you are assigned will be decided by chance (at random). Neither you nor the study doctor will know which study drug you are receiving. This is done to ensure the results of the study cannot be unfairly influenced by anyone. Notes Please use the following space to make notes or write down any questions you have for the study site staff. Participants assigned to one of the groups will be given the original trastuzumab, while participants assigned to the other group will be given the potential biosimilar to trastuzumab. All patients in the study will also receive treatment with paclitaxel, a chemotherapy agent that is commonly used in combination therapy for breast cancer. The REFLECTIONS B study will use a study drug dosing and assessment schedule that is typical for this setting. You would receive weekly intravenous infusions (a solution administered into your vein) of study drug for up to 8 months, with the option to continue with this regimen (either trastuzumab or trastuzumab biosimilar) or less frequent dosings for as long as you and your study doctor agree you are benefiting. On the days of study drug dosing the infusion time may take more than 4 hours. You may choose to bring a book or magazine with you to help to pass the time. What would I need to do? During the study, you would need to visit the study center weekly at first for study drug dosing and assessments. The frequency may reduce to every 3 weeks later in your participation in the study depending on the options you and your study doctor choose. An outline of the different procedures required during the different study visits is given below: Visit Screen Cycle 1 Dosing period Cycles with weekly treatment Cycles with dosing every 3 weeks End of study drug dosing Cycle day 28 Days Prior Physical examination X X X X X X X Blood work X X X X X X X X X Heart assessments X Weeks 9, 17, 25, 33, 41 and 53, then every 12 weeks X Study drug infusions X X X X X X X X X X Tumor assessments X Weeks 9, 17, 25, 33, 41 and 53, then every 12 weeks Follow-up 6 months beyond study drug dosing It is important that you attend each of your scheduled appointments.

4 Is there anything else that I should know? As with most things, there may be some risks and discomforts involved in taking part in a clinical study. However, the safety of participants is monitored during every stage of the process: Before the study Every study is closely regulated and must be reviewed by an independent ethics committee (IEC) / Institutional Review Board (IRB), which is a committee that has been formally designated to monitor and review biomedical and research involving humans. The committee is made up of healthcare/research professionals and non-medical members who have the qualifications and experience to review the ethics, science, and medical aspects of the clinical study and is responsible to protect the rights, safety and well being of human research subjects. If you decide to join, the study will be carefully explained to you and you will be given the chance to ask questions. You will then be asked to sign an Informed Consent Document to show you understand and agree to what the study involves. During the study While the study is ongoing, a specialist team of study doctors and nurses at the study center will monitor your health closely. This study will be blinded. This means that the volunteers and the researchers conducting and overseeing the trial will not be made aware of which study drug you will be receiving until the study is completed. This information is available in case of emergency. Like all medicines, trastuzumab and paclitaxel can cause side effects, although not everybody gets the same side effects. Most side effects are mild to moderate but some may be serious and require treatment or hospitalization. Reactions during or soon after trastuzumab or paclitaxel infusions can occur. These can include allergic type reactions, chills, fever, flu-like symptoms and other events. Rarely, infusion reactions can become serious. Other side effects can include heart problems during or after dosing, low blood cell counts, feeling tired, hair loss, numbness in your hands or feet (neuropathy), joint or muscle pain, nausea, vomiting and other effects. The study team would discuss with you all of the side effects that could be anticipated before you make the decision to participate in the study. If you join the study and change your mind at a later date, you are free to leave the study at any time. No financial incentive is offered to participants, but you may be reimbursed for travel and expenses. The study drugs and procedures are provided at no cost. Also, all patients participating in this REFLECTIONS B study will receive study-related care during the study, and their health will be monitored throughout. Taking part in a study doesn t guarantee your health will improve. Because breast cancer is a long-term condition, you should ensure that you have regular contact with medical professionals. Keep all appointments with your healthcare team, and discuss any changes you have noticed in your symptoms. What should I do now? If you are interested in joining this REFLECTIONS B study or would like further information, please contact the study site staff on the number provided on the back cover of this brochure. If both you and your study doctor think that you may be eligible for this REFLECTIONS B study, you will be asked to sign an informed consent form to show that you: Understand what the study involves Agree to take part. You will then be invited for a screening visit to ensure that you fully meet the requirements of the study. Thank you for your time and interest in this REFLECTIONS B study.

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