UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
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Study Title: MPA Revisited: A Phase II Study of Anti-Metastatic, Anti-Angiogenic Therapy in Postmenopausal Patients with Hormone Receptor Negative Breast Cancer
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This is a clinical trial, a type of research study. Your study doctor(s), Hope Rugo, MD and her associates at the University of California, San Francisco (UCSF) Medical Center and UCSF/Mount Zion Cancer Center will explain the clinical trial to you.
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Clinical trials include only people who choose to take part. Please take your time to make your decision about participating. You may discuss your decision with your family and friends and with your health care team. If you have any questions, you may ask your study doctor.

You are being asked to take part in this study because you have breast cancer that has recurred or spread to other parts of the body.
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Why is this study being done?

The purpose of this study is to determine if medroxyprogesterone acetate (abbreviated MPA) is an effective treatment for estrogen receptor negative (ER-) breast cancer. MPA has been used in the past to treat ER+ breast cancer. Based on recent laboratory studies, we think MPA alone or in combinations with low dose oral chemotherapy might be an effective treatment for ER- breast cancers as well. This study will determine if this is true.
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This study is funded by UCSF through the Translational Breast Cancer Research Consortium. The study sponsor is Indiana University.
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How many people will take part in this study?

Between 30 and 50 people will take part in this study, including about 5 patients from UCSF. The first 15-25 patients will be treated with MPA alone. A second group of 15-25 patients will be treated with MPA plus low dose oral chemotherapy using two drugs called cyclophosphamide and methotrexate.
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What will happen if I take part in this research study?
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BEFORE YOU BEGIN THE STUDY

You will need to have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your doctor.
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  1. History and physical examination
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  2. Height and weight
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  3. Performance status (an overall assessment of the impact your breast cancer and other factors have on your daily life)
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  4. Laboratory testing of blood
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  5. X-rays or CT scans to evaluate your breast cancer
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IF YOU AGREE AND PROVIDE INFORMED CONSENT, SOME OF THE TISSUE THAT WAS COLLECTED FROM YOUR ORIGINAL BREAST CANCER DIAGNOSIS WILL BE RETAINED FOR FUTURE RESEARCH. A SEPARATE SECTION AT THE END OF THIS CONSENT FORM PROVIDES DETAILS ABOUT THIS OPTIONAL PART OF THE STUDY.
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DURING THE STUDY
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If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will need the following tests and procedures. These tests would not be done if you were not part of this study. You will not be charged for these tests.
  1. A skin biopsy, before starting treatment and again after you have been on treatment for 4 weeks. The biopsy will be taken from an inconspicuous place (most commonly from the back of the upper arm) and will be about 4 millimeters, in size (about the size of a dime). The skin biopsy is being done to evaluate the effect of the study drug. MPA, on proteins in the skin. In animals who received MPA, a decrease in one of the proteins was associated with a tumor response.
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  2. Additional blood tests before starting treatment, at week 3, week 5, week 9 and every 8 weeks thereafter.
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The following tests will be done as part of your regular cancer care.
  1. Ongoing physical exams at week 1, week 5, week 9 and every 8 weeks thereafter
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  2. Routine laboratory tests of blood at week 1, week 5, week 9 and every 8 weeks thereafter
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  3. Periodic x-rays or CT scans to evaluate your cancer every 8 weeks
If you are assigned "Arm A" - MPA alone You will be asked to take MPA by mouth once a day. A blood sample will be taken after you have been taking MPA for 10-15 days to measure the level of MPA in your blood. If this level is too low, you may be asked to take a higher dose of MPA each day.
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We will evaluate the effect of the MPA on your tumor with x-rays or CT scans after you have been taking MPA for 8 weeks and then every 8 weeks thereafter.
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If you are assigned to "Arm B" - MPA + low dose chemotherapy

You will be asked to take MPA by mouth once a day. A blood sample will be taken after you have been taking MPA for 10-15 days to measure the level of MPA in your blood. If this level is too low, you may be asked to take a higher dose of MPA each day.
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You will also be asked to take cyclophosphamide by mouth once a day and methotrexate by mouth twice a day for the first two days of each week only. We will evaluate the effect of the MPA + low dose chemotherapy on your tumor with x-rays or CT scans after you have been taking MPA for 8 weeks and then every 8 weeks thereafter.
  1. Study location: All study procedures will be done at the UCSF Breast Care Center located at the UCSF Mt Zion Cancer Center
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  2. Blood drawing (venipuncture): At screening and at various times throughout your participation in the study a blood sample will be drawn by inserting a needle into a vein in your arm.
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  3. X-ray: At screening and at various intervals throughout your participation in the study, you may have an x-ray to evaluate your cancer.
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  4. CT scan: At screening and at various intervals throughout your participation in the study, you may have a computed tomography (CT) [/computerized axial tomography (CAT)] scan to evaluate your cancer. A CT scan uses special x-ray equipment to make detailed pictures of body tissues and organs.
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  5. For the CT scan, you will need to lie still on a table. The table will move and the machine will make clicking and whirring noises as the pictures are taken. Each CT scan will take about 15 minutes to a half hour.
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How long will I be in the study?

You will continue taking the study medication until your tumor grows, until unacceptable side effects occur, you withdraw your consent, or your doctor thinks you should stop treatment. The doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest; if you do not follow the study rules; or if the study is stopped.
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Can I stop being in the study?

Yes. You can decide to stop at any time. Tell the doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely. It is important to tell the doctor if you are thinking about stopping so any risks from the MPA and/or chemotherapy can be evaluated by your doctor. Another reason to tell your doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you. The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.
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What side effects or risks can I expect from being in the study? You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, doctors don't know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop taking the study drugs. In some cases, side effects can be serious, long lasting, or may never go away. Death is rare, but possible.
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  1. Risks and Side Effects related to MPA include those which are:
    1. More likely
      1. Weight gain
      2. Increased appetite
      3. Fluid retention or swelling
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    2. Less likely
      1. Hot flashes
      2. Milky discharge from the breast
      3. Vaginal bleeding or spotting
      4. Nausea
      5. Itching
      6. Rash
      7. Hair thinning
      8. Acne
      9. Hair growth on the chin
      10. Fatigue
      11. Difficulty sleeping
      12. Nervousness
      13. Blood clot in the legs
      14. Headache
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    3. Rare
      1. Jaundice or yellowing of the skin
      2. Severe allergic reaction
      3. Depression
      4. Dizziness
      5. Blood clot in the lungs
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  2. Risks and Side Effects related to Cyclophosphamide + Methotrexate include those which are
    1. More likely
      1. Headaches
      2. Nausea, vomiting
      3. Fatigue
      4. Decreased appetite
      5. Diarrhea
      6. Sore mouth or sore throat
      7. Increased appetite
      8. Fluid retention or swelling
      9. Low blood count that could increase risk of infection
      10. Low blood count that could increase risk of bruising or bleeding
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    2. Less likely
      1. Redness, peeling or tenderness of the hands and feet
      2. Nail changes
      3. Skin rash
      4. Itching
      5. Hair thinning
      6. Headache
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    3. Rare
      1. Jaundice or yellowing of the skin
      2. Elevated liver function tests which may show possible damage to your liver cells
      3. Irritation of the bladder
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  3. Blood drawing (venipuncture) risks: Drawing blood may cause temporary discomfort from the needle stick, bruising, and infection.
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  4. Skin Biopsy

    The risks of having a skin biopsy include pain, bruising, bleeding and rarely infection. The skin biopsy may leave a scar about the size of a pencil eraser. The skin biopsy will be done by your doctor or an experienced nurse. A numbing medication will be applied to the skin before the biopsy to minimize discomfort. An antibiotic cream will be applied after the biopsy to decrease the risk of infection.
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  5. Radiation (x-ray) risks:

    The amount of radiation you will be exposed to is relatively small. Such doses of radiation may be potentially harmful, but the risks are so small that they are difficult to measure. If you have already had many x-rays, you should discuss this with the researchers before agreeing to be in the study.
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  6. CT scan risks:

    CT scans involve the risks of radiation (see above). In addition, if contrast material (iodine dye) is used, there is a slight risk of developing an allergic reaction, from mild (itching, rash) to severe (difficulty breathing, shock, or rarely, death). The contrast material may also cause kidney problems, especially if you are dehydrated or have poor kidney function. The study doctors will ask you about any allergies or related conditions before the procedure. If you have any of these problems, you may not be allowed to have a CT scan.
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    Having a CT scan may mean some added discomfort for you. In particular, you may be bothered by feelings of claustrophobia when placed inside the CT scanner, or by lying in one position for a long time. If contrast material is used, you may feel discomfort when it is injected. You may feel warm and flushed and get a metallic taste in your mouth. Rarely, the contrast material may cause nausea, vomiting or a headache
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  7. Reproductive Risks:

    MPA, cyclosphosphamide and methotrexate can be harmful to a fetus. Only postmenopausal women may participate in this study. If at any time during the study you suspect that you have become pregnant, please notify the study doctor immediately.

  8. Unknown Risks:
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    The experimental treatments may have side effects that no one knows about yet. The researchers will let you know if they learn anything that might make you change your mind about participating in the study.

  9. For more information about risks and side effects, ask your study doctor.
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Are there benefits to taking part in the study?

Taking part in this study may or may not make your health better. While doctors hope this treatment will be effective for your cancer, there is no proof of this yet. The information learned in this study could help future cancer patients.
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What other choices do I have if I do not take part in this study?
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Your other choices may include:
  1. Getting treatment or care for your cancer without being in a study.
  2. Taking part in another study.
  3. Getting no treatment.
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Talk to your doctor about your choices before you decide if you will take part in this study. You may receive treatment at this center even if you decide not to participate in this research study. Please talk to your regular doctor about these options.
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Will my medical information be kept private?

We will do our best to make sure that the personal information in your medical record is 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.
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Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
  1. UCSF's Committee on Human Research
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  2. The National Cancer Institute (NCI) and other government agencies, e.g ., the Food and Drug Administration (FDA), involved in keeping research safe for people

  3. The sponsor(s) of the study: Indiana University
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What are the costs of taking part in this study?

You and/or your health plan/insurance company will need to pay for some or all of the costs of treating your cancer in this study. Some health plans will not pay these costs for taking part in studies. Check with your health plan/insurance company to find out what they will pay for. Taking part in this study may or may not cost you or your insurance company more than the cost of getting regular cancer treatment.
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The sponsor of this study will supply the study drug MPA at no cost to you. Costs associated with your care, such as laboratory tests, x-rays, scans, clinic visits, other medications, and hospitalizations are all considered a part of standard care for someone with breast cancer; therefore you will be responsible for these costs. Cyclophosphamide and methotrexate are commonly used to treat breast cancer therefore you will be responsible for the cost of these drugs.
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Certain lab tests or procedures are required for the research that are not considered a part of standard care for your breast cancer, and the costs for these specified tests, will be paid for by the study.
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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/insurance-coverage
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You can print a copy of the "Clinical Trials and Insurance Coverage" information from this Web site.

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.

Will I be paid for taking part in this study?
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You will not be paid for taking part in this study.

What happens if I am injured because I took part in this study?

It is important that you tell your study doctor, Hope Rugo, MD or her associates if you feel that you have been injured because of taking part in this study. You can tell the doctor in person or call him/her at 415 353-7070.
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Treatment and Compensation for Injury:

If you are injured as a result of being in this study, treatment will be available. The costs of the treatment may be covered by the University of California, depending on a number of factors. The University does not normally provide any other form of compensation for injury. For further information about this, you may call the office of the Committee on Human Research at 415- 476-1814.
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What are my rights if I take part in this study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution.
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We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.

In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.

Who can answer my questions about the study?
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You can talk to your study doctor about any questions or concerns you have about this study. Contact your study doctor, Hope Rugo, MD and her associates at (415) 353-7070.

For questions about your rights while taking part in this study, call the office of the Committee on Human Research, UCSF's Institutional Review Board (a group of people who review the research to protect your rights) at 415-476-1814


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Please note: This section of the informed consent form is about an additional research study that is being done with people who are taking part in the main study. You may take part in these additional studies if you want to. You can still be a part of the main study even if you say "no" to taking part in any of these additional studies.

You can say "yes" or "no" to following study. Please mark your choice for each study.
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About Using Tissue for Research

We would like to collect some of the tissue that was collected from your original breast cancer diagnosis for future research. If you agree, this tissue will be kept and may be used in research to learn more about cancer and other diseases. The research that may be done with your tissue will probably not help you. It might help people who have cancer and other diseases in the future.
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Reports about the research done with your tissue will not be given to you or to your doctor. These reports will not be put into your health record. The research will not have an effect on your care.

Things to Think About

The choice to let us keep the leftover tissue for future research is up to you. No matter what you decide to do, it will not affect your care, and you may still take part in this study. Your tissue will be used only for research, and it will not be sold. You will not be paid for allowing your leftover tissue to be used in research, even though the research done with your tissue may help to develop new products in the future. Similarly, there will be no cost to you for any tissue collected and stored for this study.
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Sometimes tissue is used for genetic research (about diseases that are passed on in families). Even if your tissue is used for this kind of research, the results will not be put into your health records.

The tissue specimens will be stored at the NCI Department of Pathology in Bethesda, MD. To protect your privacy, your samples and medical information will be labeled (or "coded") with your study subject number, not your name. Your study doctor and his or her staff will keep the link between your subject number and your name. Any patient information linked to the code will be maintained in a secure database.
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Samples will be kept indefinitely or until the specimens have been used up. Only the designated NCI pathologist and study personnel will have access to the specimens.

If you decide now that your tissue can be kept for research, you can change your mind at any time. Just contact your study doctor via telephone or in writing to let him or her know that you do not want us to use your tissue. Then the remaining tissue will be destroyed and will no longer be used for research.
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Benefits

The benefits of research using tissue include learning more about what causes cancer and other diseases, how to prevent them, and how to treat them.

Risks

The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small.
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Making Your Choice

Please read each sentence below and think about your choice. After reading each sentence, put your initials in the "Yes" or "No" box. If you have any questions, please talk to your doctor or nurse, or call our research review board at IRB's phone number.

No matter what you decide to do, it will not affect your care.

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  1. My tissue may be kept for use in research to learn about, prevent, or treat cancer.

    YES NO
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  2. My tissue may be kept for use in research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart ease).

    YES NO

  3. Someone may contact me in the future to ask me to take part in more research.
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    YES NO


CONSENT

You have been given copies of this consent form and the Experimental Subject's Bill of Rights to keep.
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You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health information about you.

PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.

If you wish to participate in this study, you should sign below.


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Date


Participant's Signature for Consent


Date


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Person Obtaining Consent


Date


Signature of Translator (if applicable)



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080752 CONSENT FORM MARCH 25, 2009

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