Clinical trial: NCT00796978
Section: Alternatives
Subsections: Alternatives To Participation

You may choose not to take part in this study. If you decide not to participate, you can discuss your alternative therapy options to treat your breast cancer with your doctor. There are other approved treatments available for your cancer. For example, you may choose to receive chemotherapy in combination with TRASTUZUMAB which is the standard treatment, chemotherapy alone, or radiation therapy. You may choose to receive no therapy or just receive medications to improve your comfort and reduce the pain associated with your cancer. You could also consider participation in another clinical study. Your doctor or the study doctor can explain the other treatments that are available to you.   
  
P (Herceptin®) in Older Women with Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial University Hospitals Principal Investigator: **Cynthia Owusu, M.D.**  
What are the costs of taking part in this study? You will not be paid for taking part in this study. You will not be responsible for the cost of research related visits including the study procedures and laboratory tests that are directly due to your taking part in this study. TRASTUZUMAB will be provided for free with this study. You and/or your health plan/insurance company will be responsible for the cost of the personnel required to give this drug. All of the medical tests, evaluations, procedures and recommendations that are considered standard cancer care will be the responsibility of you and your insurance company. For more information on clinical trials and insurance coverage, you can visit the National Cancer Institute's Web site at http://cancer.gov/clinicaltrials/understanding/insurancecoverage. You can print a copy of the "Clinical Trials and Insurance Coverage" information from this Web site. Expenses such as parking, travel, and lodging associated with the study will not be reimbursed to you. Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237) and ask them to send you a free copy.
Clinical trial: NCT00796978
Section: Confidentiality
Subsections: Confidentiality|Hipaa Authorization Section Authorization To Use Or Disclose (Release) Health Information That Identifies You For A Research Study|Disclosure Of Your Study Records

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. If you decide to participate in the study, the study doctor and staff will collect medical and personal information in a centralized computer or data registry at the Seidman Cancer Center, Cleveland, Ohio. Members of independent ethics committee or the institutional review board (IEC/IRB) for the study will have access to this information at the site in order to check that the study is done properly. Your permission to the study doctor and staff to use this information or share it with others as described below for the study doesn't automatically end at a particular time. You should know that once identifiable medical information about you is given to someone that is not a health care provider, it is not protected by the US federal privacy rules called the HIPAA Privacy Regulations

If you volunteer to participate in this research, your protected health information (PHI) that identifies you will be used or disclosed to Cynthia Owusu, M.D. and her research staff at Case Western Reserve University, University Hospitals Cleveland Medical Center; as well as Genentech, Inc. for the purposes of this research and to Case Western Reserve University for administration.  
The PHI that we may use or disclose (release) for this research includes:
your name, initials, address, telephone number, date of birth and other demographic information; your medical history (including the history and diagnosis of your disease and your family medical history) and the name of your physician(s) and locations where you received any treatment; specific information about the treatment/therapy you receive during the Research Study and treatment you received prior to the Research Study (including treatments and therapies, surgeries, hospitalizations and medications);  
   
P (Herceptin®) in Older Women with Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial University Hospitals Principal Investigator: **Cynthia Owusu, M.D.**  
information about other medical conditions that may affect your treatment, including information relating to mental health, behavioral health and psychiatric disorders; Human Immunodeficiency Virus (HIV) test results, Acquired Immunodeficiency Syndrome (AIDS), and AIDS-related conditions; and alcohol and drug dependence or abuse; medical data, including physical exam findings, laboratory test results, tumor measurements, CT scans, MRIs, X-rays, ultrasounds and other radiologic scans, photographs of areas of disease and pathology results; information on side effects (adverse events) you may experience and how these side effects were treated; long-term information about your general health status and the status of your disease or medical condition; data that may be related to tissue and/or blood samples that may be collected from you; numbers or codes that identify you, such as your social security number, medical record number, and Research Study case number; identifiers and serial numbers from medical devices; and your entire medical record.  
In addition to the investigators and research staff listed above, your PHI may be looked at by other groups involved with the study such as the University Hospitals Institutional Review Board, and the Case Comprehensive Cancer Center Protocol Review and Monitoring Committee. Your PHI may also be used by and/or disclosed (released) to:

Efforts will be made to keep the personal information in your research record private and confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals Institutional Review Board may review your study records. If this is a treatment study, the records must be available to the Food and Drug Administration, the study sponsor, and possibly foreign regulatory agencies. If your records are reviewed, your identity could become known.
Clinical trial: NCT00796978
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?

You will be in this study as long as your tumor has not grown larger; you have not suffered unacceptable side effects; or until you or your doctor have decided that continuing in this study is no longer in your best interest, or the study comes to an end at the end of five years. If your disease worsens, side effects become severe, new scientific developments occur that indicate that the treatment is not in your best interest, or your physician feels that this treatment is no longer in your best interest, you will be informed and the treatment will be stopped. Further treatment options would be discussed. You will receive an initial dose of TRASTUZUMAB on Day 1 and during the maintenance phase of the study you will receive treatment with TRASTUZUMAB every three weeks to complete 52 weeks of treatment.
Clinical trial: NCT00796978
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks And Discomforts What Are The Risks Of The Study?|Likely|Less Likely|Rare But Serious|Are There Benefits To Taking Part In The Study?|Research Related Injuries What Happens If An Injury Occurs?

Most drugs have side effects associated with them and the drug, TRASTUZUMAB, used in this study may involve other risks, including possible life-threatening reactions that are not known at this time. There is always a risk involved in taking an investigational drug, but you will be monitored closely for these side effects, and if your doctor thinks it is necessary, your study drug will be stopped. If you are experiencing any side effects, you should notify your doctor immediately. Many side effects go away shortly after the drugs are stopped, but in some cases side effects can be serious, long lasting, permanent and possibly fatal. You may experience some, none, or all of the following side effects.

These side effects occur in **10-24%** of patients receiving trastuzumab:
Abdominal pain  Infection Back pain  Vomiting Loss of appetite  Difficulty sleeping Dizziness  Skin rash or ulceration Shortness of breath  Allergy-type symptoms like sneezing, nasal stuffiness, and postnasal drip

These side effects occur in **3-9%** of patients receiving trastuzumab:
Flu-like symptoms  Swelling Decreased red blood cell count (may lead to tiredness, shortness of breath)
Blood tests that show changes in liver function Decreased white blood cell count (may lead to infection)
Reaction to the infusion including: fever, chills, hives, rash, joint pain, pain at the tumor site, shortness of breath, low or high blood pressure, and sweating may occur during the infusion and last about 24 hours Cardiotoxicity: Decreased ability of the heart to pump blood. If severe, you could have shortness of breath and other symptoms of heart failure. (If mild, you may not have any symptoms.)
Rapid or irregular heartbeat Depression Nerve problems that are usually temporary including pain, tingling, burning, or numb feeling (pins and needles) in the hands, feet, or area around mouth or throat, which may cause problems walking or performing activities of daily living Sore throat Voice changes Allergic reaction (including chills, rash, hives, itching, flushing, swelling, low blood pressure, wheezing, and shortness of breath)
Pain in the chest area Pain in the muscles, bones, and joints  
P (Herceptin®) in Older Women with Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial University Hospitals Principal Investigator: **Cynthia Owusu, M.D.**

These side effects occur in **less than 3%** *of patients receiving trastuzumab:*
Severe reaction to the infusion Severe allergic reaction Blood clot in a blood vessel Thrombocytopenia (a reduction in the number of platelets that may increase the risk of bleeding)  
Severe lung problems (including shortness of breath, fluid in the lungs, low levels of oxygen in the blood, and damage that could be permanent)
You will be given any new information about the study medication that becomes known during the course of this study that the study physician or the study sponsor believes might reasonably affect your willingness to continue to take part in the study. There is always the possibility that you may have a reaction or side effects that are currently unforeseen or unknown and unanticipated. It is important that you report any reactions or side effects to your study doctor. You will be monitored for side effects by study personnel and, if the side effects are severe enough you will be withdrawn from the study.

There is no guarantee that you will benefit from taking part in this study. You may receive little or no benefit from TRASTUZUMAB treatment. TRASTUSUMAB as a single agent and also in combination with chemotherapy has been proven to be very effective in the adjuvant setting for younger patients with Her2 positive breast cancer. This study proposes to explore the benefits of adjuvant TRASTUZUMAB in older women (60 years or older).

If an injury occurs as a result of your involvement in this research, medical treatment is available from University Hospitals or another medical facility; but you/your medical insurance will be responsible for the cost of this treatment. A research injury is an injury that happens as a result of taking part in this research study. If you are injured by a medical treatment or procedure that you would have received even if you weren't in the study, that is not considered a "research injury". There are no plans for payment of medical expenses or other payments, including lost wages, for any research-related injury. To help avoid injury, it is very important to follow all study directions. Genentech, Inc., who provides funding for this study, will not provide financial assistance for injury, medical or other costs. Additionally, Genentech, Inc. will not pay for lost wages or other damages or losses or for medical expenses that have been covered by medical or hospital insurance or by third party or governmental programs providing such coverage.  
  
P (Herceptin®) in Older Women with Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial
Clinical trial: NCT00796978
Section: Procedures
Subsections: What Is Involved In This Study

During this study you will have the following exams and procedures. The exams and procedures are described below and summarized in the Study Calendar on page 5. Before you begin the study… If you agree to take part in this study, you will be asked to sign this consent form. You will then have certain examinations and tests (called "screening tests") to help your study doctor determine if you are eligible to receive treatment as part of this study. Many of the following evaluations are part of regular cancer care and may be done even if you do not join the study. If you have had some or all of these evaluations recently, they may not need to be repeated. Your doctor will decide if tests need to be repeated.  
You will have the following assessment tests within 21 days of starting treatment:
Physical exam; including height, body weight and vital signs (blood pressure, pulse rate, body temperature).
Clinical trial: NCT00796978
Section: Purpose of Research
Subsections: Information About The Research Why Are You Being Asked To Take Part In This Research?|Why Is This Study Being Done?

You are being asked to participate in a research study of early-stage Her2 positive invasive breast cancer. Her2 positive means that the cancer makes too much of a protein called Her2. Too much of this protein can cause normal cells to receive too many growth signals which can turn a normal cell into a cancer cell and can change the way it responds to treatment. TRASTUZUMAB (Herceptin®) targets Her2-positive breast cancer cells and blocks the Her2 protein on the surface of the cancer cell to slow down or stop cancer growth. TRASTUZUMAB (made by Genentech, Inc.) in combination with chemotherapy is a standard treatment for early-stage Her2-positive breast cancer that is larger than 1cm. Trastuzumab is currently not recommended for patients with breast cancer that is lcm or less in size. However some patients are unable or unwilling to undergo treatment with chemotherapy. The purpose of this study is to determine if for those patients who are unable or unwilling to undergo treatment with the combination of TRASTUZUMAB
(Herceptin®) and chemotherapy, trastuzumab alone is safe and can control cancer effectively, irrespective of the size of breast cancer.

TRASTUZUMAB alone or in combination with chemotherapy has proven to be very effective in the adjuvant setting for younger patients with Her2-positive breast cancer. Although older patients have a greater incidence and death rate from cancer, they have been under-represented in clinical trials, particularly, breast cancer clinical trials. The main purpose of this study is to determine the benefit of adjuvant treatment with TRASTUZUMAB without chemotherapy in older women (60 years of age, or older).
Clinical trial: NCT00796978
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risks or benefits associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating. If you experience physical injury or illness as a result of participating in this research study, medical care is available at University Hospitals Cleveland Medical Center or elsewhere; however, University Hospitals Cleveland Medical Center have no plan to provide free care or compensation for lost wages.  
  
P (Herceptin®) in Older Women with Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial University Hospitals Principal Investigator: **Cynthia Owusu, M.D.**
Clinical trial: NCT00796978
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?

Yes. You can decide to stop participating in this study at any time. Tell the study doctor if you are thinking about stopping and he or she will tell you how to stop safely, and discuss what follow-up care and testing will be right for you. It is important to tell your doctor if you are considering stopping so that any risks from the medications can be evaluated. Refusing to participate will involve no penalty, loss of benefits, or prejudice to your later care. If you do not take part in the study, or if you withdraw from the study, you will continue to receive care. In the event that you withdraw from the study, you will continue to be followed and clinical data will continue to be collected from your medical records.