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Brought to you by HER Breast Cancer Handbook Information about the testing and treatment of HER2-positive early-stage (adjuvant) breast cancer References: 1. American Cancer Society. Breast Cancer Facts and Figures 2015-2016 p1/Table1. http://www.cancer.org/acs/groups/ content/@research/documents/document/acspc-046381.pdf. Accessed June 2, 2016. 2. Stages of breast cancer. National Cancer Institute. http://www.cancer.gov/cancertopics/pdq/treatment/breast/patient/page2. Accessed June 2, 2016. 3. Tumor grade. National Cancer Institute. http://www.cancer.gov/cancertopics/factsheet/detection/tumor-grade. Accessed June 2, 2016. 4. Testing biopsy and cytology specimens for cancer. American Cancer Society. http://www.cancer.org/acs/groups/ cid/documents/webcontent/003185-pdf. Accessed June 2, 2016. 5. Pegram M, Slamon D. Biological rationale for HER2/ neu (c-erbB2) as a target for monoclonal antibody therapy. Semin Oncol. 2000;27(suppl 9):13-19. 6. Hormone receptor status. Breastcancer.org. http://www.breastcancer.org/symptoms/diagnosis/hormone_status. Accessed June 2, 2016. 7. HercepTest™ Interpretation Manual—Breast. Dako Denmark A/S. February 19, 2010. 8. Wolff AC, Hammond MEH, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013;31(31):3997-4013. 9. HER2 status. Breastcancer.org. http://www.breastcancer.org/symptoms/diagnosis/her2. Updated May 16, 2016. Accessed June 2, 2016. 10. Treatment option overview. National Cancer Institute. http://www.cancer.gov/cancertopics/pdq/treatment/ breast/patient/page5. Accessed June 2, 2016. 11. American Cancer Society. Types of cancer treatment. http://www.cancer. org/treatment/treatmentsandsideeffects/treatmenttypes/index. Accessed June 2, 2016. 12. Herceptin Prescribing Information. Genentech USA, Inc. 2016. Who is HERCEPTIN for? Herceptin is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways: • As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC TH” • With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH” • Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy) igh risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor H grade 2 or 3. * Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. ©2016 Genentech USA, Inc. So. San Francisco, CA All rights reserved. Printed in USA. HER/051215/0018a(2) 04/16 What possible Serious Side Effects and Additional Important Safety Information should I know about Herceptin? Not all people have serious side effects, but side effects with HERCEPTIN therapy are common. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. HERCEPTIN is not for everyone. Be sure to contact your doctor if you are experiencing any of the following: HEART PROBLEMS These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both HERCEPTIN and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with HERCEPTIN. INFUSION REACTIONS, including: • Fever and chills • Feeling sick to your stomach (nausea) • Throwing up (vomiting) • Pain (in some cases at tumor sites) • Headache • Dizziness • Shortness of breath These signs usually happen within 24 hours after receiving HERCEPTIN. 2 Be sure to contact your doctor if you: Are a woman who could become pregnant, or may be pregnant Treatment with HERCEPTIN may result in the death of an unborn baby and birth defects. Birth control should be used while receiving HERCEPTIN and after your last dose of HERCEPTIN. If you are exposed to HERCEPTIN during pregnancy or within 7 months of becoming pregnant, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting http://www.motherpregnancyregistry.com/ and to report HERCEPTIN exposure to Genentech at 1-888-835-2555. advocacy What will groups I learn in this handbook? The basics of breast cancer ................ pages 4-9 The basics of HER2 .................................. pages 10-13 Herceptin and Possible Serious Side Effects ............. pages 14-19 Patient support ............................................ pages 20-25 The information in this brochure is not intended to replace the advice of your doctor. If you have any questions about your treatment, be sure to contact your healthcare team. Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 3 What is breast cancer? Breast cancer is a tumor that begins in the breast advocacy groups Living Beyond Breast Cancer www.lbbc.org or call 1-888-753-5222 Lymph Nodes Fat This nonprofit organization is dedicated to empowering all women affected by breast cancer to live as long as possible with the best quality of life. American Cancer Society www.cancer.org or call 1-800-227-2345 This comprehensive website offers information for patients with cancer as well as families, friends, survivors, professionals, and volunteers. Nipple National Cancer Institute www.cancer.gov or call 1-800-4-CANCER (1-800-422-6237) Ducts This website provides easy access to comprehensive research-based information and resources for cancer researchers, health professionals, patients and their families, advocates, news media, and the public. Lobules ! 4 *The organizations here are an incomplete listing of cancer support organizations and are not controlled by, endorsed by, or affiliated with Genentech USA, Inc. The list is meant for informational purposes only and is not meant to replace your healthcare professional’s medical advice. Ask your doctor or nurse any questions you may have about your cancer or treatment plan. An estimated 231,840 women were diagnosed with breast cancer in the United States in 2015.1 Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 25 What are the potential risk factors? While we aren’t sure of exactly what causes breast cancer, we are aware of certain risk factors1: •Diet •Smoking • Age • Family history Breast cancer is discovered typically when either a patient or physician finds a lump in the breast. This can happen during a self-examination or a mammogram. However, there are other symptoms of breast cancer that may or may not be present1: •Swelling of the breast • Nipple discharge •Breast or nipple pain •Nipple retraction (turning inward) •Skin irritation on the breast Diagnosis is confirmed after a biopsy is taken and analyzed by a pathologist. 5 5 What are the stages of breast cancer? What are the other characteristics of breast cancer? Tumor size and tumor grade can affect treatment decisions Stage refers to how much the cancer has grown and where it has spread. Tumor size 5 cm 4 cm 3 cm 2 cm Stage 0 cancer does not interfere with normal breast tissue and is confined to the breast.2 Stage I cancer interferes with normal breast tissue and may have spread to the lymph nodes.2 Stage II cancer interferes with normal breast tissue and may have spread to the lymph nodes under the arm.2 1 cm T1 T2 T3 Tumor grade3 Stage IIIA cancer interferes with normal breast tissue and has spread to the lymph nodes under the arm or near the breastbone.2 6 Stage IIIB/C cancer has spread to the chest wall and/or skin of the breast, as well as to the lymph nodes under the arm, near the breastbone, or near the collarbone.2 Grade 1 Grade 2 Grade 3/4 Cells are not growing rapidly Cells are growing at a moderate rate Cells are growing and spreading aggressively Stage IV cancer has spread to other organs in the body, such as the liver or brain.2 Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 7 What are the different types of breast cancer surgeries? Surgery is often the first type of therapy used in breast cancer1 •There are several surgical options that your doctor will choose from, based on what is best for you What happens after surgery? After surgery, a sample of your tumor is taken to a pathology lab to be analyzed Pathologist’s responsibilities4: •The pathologist will take your sample and prepare it for testing. There are many different steps that must be taken to ensure your sample is accurately tested •Once the sample is prepared for testing, the pathologist will run the appropriate test based on the type of suspected cancer •The pathologist will then analyze the sample and create a report based on the findings 8 Lumpectomy Mastectomy Lymph Node Dissection Only the breast tumor is removed, as well as some surrounding normal tissue. The removal of the entire breast. After the procedure, breast reconstruction may be an option. The lymph nodes near the breast are removed to determine whether the cancer has spread to the nodes. Lymph node dissections often accompany lumpectomies and mastectomies. Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 9 What does the pathologist test for? The pathologist will test the tumor for certain traits that may affect treatment decisions HER2 status5 • HER2 refers to HER2 receptors •All cells have HER2 receptors, which are proteins found on the surface of cells. However, in HER2-positive breast cancer, cancer cells have a higher-than-normal number of HER2 receptors •Having too many HER2 receptors may make the cancer grow and divide faster, creating more HER2-positive cancer cells Hormone-receptor status6 •The presence of hormone receptors in your breast cancer cells means that these cells grow when hormones from your body attach to these receptors •The 2 types of hormone receptors you may hear about are estrogen receptors (ER) and progesterone receptors (PR) •If you have estrogen or progesterone receptors, your breast cancer is estrogen receptor-positive (ER+) or progesterone receptor positive (PR+) and you have hormone receptor-positive (HR+) breast cancer 10 How is HER2 testing conducted? The most common methods for testing HER2 IHC FISH Breast cancer cells are examined under a microscope to see whether there is too much HER2 protein present on the cell surface. The cell nucleus controls cell growth and reproduction. FISH testing measures the number of copies of the HER2 gene in the nucleus. (immunohistochemistry) (fluorescence in situ hybridization) •The pathologist will interpret the results and score the patient as HER2-positive, HER2-negative, or equivocal (which means that the tumor is considered neither HER2-positive nor HER2-negative) •IHC test results are scored as negative (0 or 1+), equivocal (2+), or positive (3+)7 •FISH test results are scored as negative, equivocal, or positive8 ! If you have questions about HER2 testing or your HER2 results, please contact your healthcare team. Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 11 Why is HER2 testing important? HER2 testing •You must have a HER2 test to determine if your cancer is HER2-positive before taking Herceptin, as treatment benefit has only been shown in patients whose tumors are HER2-positive How might HER2 status impact your treatment? The results of your HER2 test, based on the pathology review, are given to your oncologist to help determine the appropriate course of treatment Approximately 1 in 5 patients is HER2-positive, so it is important to find out your HER2 status5,9 Pathology Results HER2 Testing Method: Percent Staining: Normal cell HER2-positive cancer cell IHC Score: HER2 Status: Pathologist In a normal breast cancer cell, HER2 receptors send signals telling cells to grow and divide. HER2-positive breast cancer cells have too many HER2 receptors, which may make cancer cells grow and divide faster. HER2-positive breast cancer is considered aggressive because it grows and spreads more quickly5 12 Pathology Report ! Oncologist Patient Accurate HER2 testing is extremely important. If you are HER2-positive, you can potentially benefit from a therapy that targets HER2. To learn more about pathology reports, visit www.breastcancer.org/symptoms/diagnosis Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 13 What are the different therapies used to treat breast cancer? What is Herceptin? There are a number of therapies used in the treatment of breast cancer. Your doctor will determine which therapy is best for you10,11 Herceptin is a targeted therapy designed to combat tumor cell growth in HER2-positive breast cancer12 Surgery is the removal of cancer from the breast. How Herceptin may work In preclinical studies, Herceptin was shown to attach to HER2 receptors Radiation therapy uses high-energy rays to kill tumor cells and/or shrink tumors. Inside the cell Chemotherapy is a type of medicine that kills cells •Herceptin may stop the HER2 that grow and divide rapidly; these can include cancer cells or normal cells. receptors from telling the cell to grow Hormonal therapy helps fight against tumors that Outside the cell thrive on hormones like estrogen and progesterone by blocking hormone receptors. •In preclinical studies, it was shown that once bound to the HER2 receptor, Herceptin may be able to flag tumor cells for destruction by the immune system Targeted therapy is different from other types of therapy. Targeted therapy is a type of medicine that is designed to attack specific cancer cells, but may also affect healthy cells. Possible Serious Side Effects: Heart Problems 14 These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both HERCEPTIN and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with HERCEPTIN. • Normal cells also have HER2 (just not as much), so HER2-targeted therapies can also affect healthy cells and can cause side effects, including serious side effects Herceptin can be taken with certain chemotherapies Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 15 Why is heart monitoring necessary while receiving Herceptin therapy? Your healthcare team will monitor your heart to stay on top of potential cardiac issues and catch them early on so they can be properly treated12 Your heart will be monitored at baseline, every 3 months while on a 1-year course of Herceptin therapy, and upon completion. Heart function will be tested with an ECHO* or MUGA† scan12 DURING HERCEPTIN THERAPY12 AFTER HERCEPTIN THERAPY12 HOLDING HERCEPTIN In case of reduced heart function without symptoms, your doctor may hold Herceptin therapy up to 3 times. your heart should be monitored every 6 months for at least 2 years RESTARTING HERCEPTIN Your doctor may restart Herceptin therapy up to 3 times if your heart function improves and returns to normal limits after Herceptin has been held. DISCONTINUING HERCEPTIN Herceptin will be discontinued if you experience CHF or significantly reduced heart function (when the heart can’t keep up with the amount of blood flowing through it). Possible Serious Side Effects: INFUSION REACTIONS, including: • Fever and chills • Headache • Feeling sick to your stomach (nausea) • Dizziness • Throwing up (vomiting) • Shortness of breath Pain (in some cases at tumor sites) • These signs usually happen within 24 hours after receiving HERCEPTIN. *ECHO scan is an ultrasound image of the heart. MUGA scan takes a moving picture of your heart pumping blood following an injection of a nontoxic radioactive substance. † 16 Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 17 What possible Serious Side Effects and Additional Important Safety Information should I know about Herceptin? Not all people have serious side effects, but side effects with HERCEPTIN therapy are common. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. HERCEPTIN is not for everyone. Be sure to contact your doctor if you are experiencing any of the following: HEART PROBLEMS These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both HERCEPTIN and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with HERCEPTIN. INFUSION REACTIONS, including: • Fever and chills • Feeling sick to your stomach (nausea) • Throwing up (vomiting) • Pain (in some cases at tumor sites) •Headache •Dizziness • Shortness of breath These signs usually happen within 24 hours after receiving HERCEPTIN. Be sure to contact your doctor if you: Are a woman who could become pregnant, or may be pregnant Treatment with HERCEPTIN may result in the death of an unborn baby and birth defects. Birth control should be used while receiving HERCEPTIN and after your last dose of HERCEPTIN. If you are exposed to HERCEPTIN during pregnancy or within 7 months of becoming pregnant, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting http://www.motherpregnancyregistry.com/ and to report HERCEPTIN exposure to Genentech at 1-888-835-2555. 18 Have any signs of SEVERE LUNG • Severe shortness of breath • Fluid in or around the lungs • Weakening of the valve between the heart and the lungs PROBLEMS, including • Not enough oxygen in the body • Swelling of the lungs • Scarring of the lungs Your doctor may check for signs of severe lung problems when he or she examines you. Have LOW WHITE BLOOD CELL COUNTS Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving HERCEPTIN plus chemotherapy than in patients receiving chemotherapy alone. Your doctor may check for signs of low white blood cell counts when he or she examines you. Other Important Information Before taking HERCEPTIN, you must have a HER2 test to determine if your cancer is HER2-positive. This is because the benefit of treatment with HERCEPTIN has been shown only in patients whose tumors are HER2-positive. Side Effects Seen Most Often With HERCEPTIN Some patients receiving HERCEPTIN for breast cancer had the following side effects: •Fever •Headache Feeling sick to your stomach (nausea) • •Feeling tired •Throwing up (vomiting) •Shortness of breath •Infusion reactions •Rash •Diarrhea •Low white and red blood cell counts Infections • •Muscle pain •Increased cough You should contact your doctor immediately if you have any of the side effects listed above. You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555. Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 19 What are the benefits of the HERConnection program? Supporting you through your journey with early-stage HER2-positive breast cancer Join this free educational program to get information and helpful advice from registered oncology nurses to help you stay on track with your treatment. Get information and resources about HER2-positive breast cancer HERConnection Patient Support Line Talk to registered oncology nurses who can answer questions about: We tailor HERConnection to your needs by: •How Herceptin is designed to work •The potential benefits and risks of Herceptin •Side effects of Herceptin •What to expect from Herceptin treatment •Finding reimbursement help for Herceptin specific points during your treatment •Sending you a series of emails and postal mailings about HER2-positive breast cancer and Herceptin treatment •Providing information and resources at The information you receive from the HERConnection Patient Support Line is not meant to replace the advice of your healthcare team. Genentech will not provide medical advice regarding your medical condition or treatment. Call 866-449-HER2 or join online at www.HERConnection.com 20 Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 21 Financial support and resources Herceptin Access Solutions® Herceptin Access Solutions may be able to help you get the medicine you need. How does Access Solutions work? Getting Started With Genentech Access Solutions When seeking help from Herceptin Access Solutions, there are 2 forms you and your doctor need to complete: To learn more about how we can help, contact us. Call (888) 249-4918 or visit Genentech-Access.com/Herceptin The Statement of Medical Necessity, or SMN—a form filled out by your doctor Genentech BioOncology Co-pay Card The Patient Authorization and Notice of Release of Information, or PAN—a form you must sign and date. This form lets us discuss your case with your doctor and your health care plan. Genentech offers the Genentech BioOncology Co-pay Card to help eligible patients with the out-of-pocket (OOP) costs associated with Herceptin. Genentech Access to Care Foundation ® The Genentech® Access to Care Foundation (GATCF) helps people who have health insurance and those who don’t. If you qualify for GATCF, you could receive Herceptin free of charge. To get started, the first thing you need to do is complete the PAN form. Be sure to fill in all required information. Herceptin Access Solutions must have a completed PAN before we can begin working with you or your doctor’s office. For Herceptin Access Solutions to work with you, you must complete and submit the PAN form. Your doctor must also complete a form called the SMN form. Once we have both the SMN and PAN forms, we can begin working with you and your doctor’s office. Your PAN form is valid for only 1 year. You must complete and submit one to Herceptin Access Solutions every year. You can complete the PAN in 1 of 2 ways: Fill out and submit the paperless PAN form online Sign a printed form and fax or mail it to us (or give it to your doctor’s office to do so) Where to find the PAN form You can find the PAN form at Genentech-Access.com/Herceptin or your doctor might give it to you. You can download the PAN form or fill it out online at Genentech-Access.com/Herceptin. 22 Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS. 23 Educational resources and There are support groups and national organizations that may be helpful to you and your family * Breastcancer.org www.breastcancer.org This website is dedicated to providing reliable and current medical information about treatment options, symptoms, diagnosis, and prevention. The site also includes up-to-date research news, online “ask the expert” conferences, and discussion boards. HER2 Support Group www.her2support.org This site offers information on news and current research for HER2-positive breast cancer, along with online message boards, which serve as forums for discussion among patients, family members, caregivers, and medical professionals. 24