Risks Associated with rHu G-CSF: RHu G-CSF may cause bone pain and
symptoms such as muscle cramps, back, and/or leg pain. Occasional skin
rashes have also been reported. RHu G-CSF may also cause a return of
preexisting inflammatory conditions such as psoriasis, eczema, and
inflammation of blood vessels. Hair thinning and an increase in the size of
the spleen, with an associated lowered platelet count, have been shown to
occur with prolonged administration of rHu G-CSF. The length of
administration within this study would not be considered prolonged
Risks Associated with Radiation Therapy: Radiation therapy given to
lumpectomy patients in this study is considered to be a standard treatment
with this type of surgery. You should discuss the possible side effects
with your radiation therapy doctor.
Other Risks: Mild pain or bruising may result from the needle sticks
required for drug injection and blood collections in this study. The risk
of infection is minimal.
For Women Who Can Bear Children: Women should not become pregnant, nor
should they breastfeed a child while participating in this study.
Doxorubicin, cyclophosphamide, tamoxifen, and octreotide may cause harm to
an unborn child. It is essential that you use effective methods of birth
control to avoid pregnancy while taking any study therapy, and for four
months (120 days) after completing or stopping all of the therapies given
in this study. Not all birth-control measures have been approved for use in
this study; you should discuss appropriate birth-control methods with your
doctor before entering the study. If you feel that you may be pregnant even
though you have used birth-control methods, you must notify your doctor
immediately and a pregnancy test may be performed.
For All Women in the Study: You must report any unusual vaginal bleeding
or pelvic discomfort, which may be a sign of uterine abnormality, to your
doctor. A yearly pelvic examination should be performed.
You should report any changes in your vision or other eye problems, to your
Because estrogens may negate the effects of tamoxifen and can stimulate the
growth of breast cancer cells, you must not use any intrauterine devices
containing hormones, take any birth-control pills, or take any
estrogen-replacement therapy, including estrogen pills, estrogen skin
patches, or estrogen vaginal creams. You should discuss with your doctor
any nonhormonal treatments for any menopausal (change-of-life) symptoms
that you have or may develop.
It is not known at this time whether the octreotide treatment, as given in
this study, will be helpful, have no effect, or be harmful.
Tamoxifen has been shown to decrease the risk of breast cancer recurrence
after appropriate surgery. For this reason, it has been approved by the FDA
for the treatment of women with breast cancer localized to the breast and
for postmenopausal women with breast cancer localized to the breast and
lymph nodes under the arm. It has also been approved for the treatment of
metastatic breast cancer in women and men. Studies have also shown that
tamoxifen can reduce the occurrence of second breast cancers in women who
are taking the drug to prevent recurrence of their original tumor. In
addition, it has been shown to lower the level of cholesterol and other
fats in the blood, and this may reduce the risk of heart disease.
Chemotherapy with doxorubicin and cyclophosphamide has been shown in many
previous studies to be of benefit in patients with breast cancer. Many of
the studies with doxorubicin and cyclophosphamide have been done in
patients who, on average, have a worse prognosis than patients eligible for
this study. Research in women similar to those eligible for this study has
shown other chemotherapy regimens to be of benefit.
Although you may not personally benefit from taking part in this study, the
knowledge gained in this study may benefit others.
TESTING & EXAMINATION: Before entering the study, you must have a
physical examination and some or all of the following tests:
chest X ray
pelvic exam (not required if you have had a hysterectomy with removal of
gallbladder ultrasound (not required if your gallbladder has been removed)
MUGA scan (an X ray to evaluate how well the heart contracts)
pregnancy test (for patients of childbearing potential)
Laboratory tests will be done during your course of treatment to determine
if the amount of drug you are receiving should be changed or delayed. Also,
the tests will help to monitor any side effects you may experience.
Additional blood samples may be collected at any time should your doctor
feel they are medically necessary.
Special Studies: Some of the tests required in this study are to check
for changes possibly caused by the octreotide treatment. These tests
include gallbladder ultrasounds and blood tests to check blood sugar,
thyroid function, and vitamin B12 levels. Even patients not receiving
octreotide are asked to have these tests for comparison, but these extra
tests do not relate to their medical condition. The cost of these
additional tests will be covered by Novartis Pharmaceutical Corporation,
the makers of octreotide. The timing of these tests is described in the
yearly summaries below.
Some patients may have had a sample of their breast tumor frozen at the
time of their surgery. If you enter this study and your doctor did freeze
some of your tumor, special tests may be done on this sample to see how
octreotide may attach to some breast tumors. Also, 2-3 tablespoons of blood
will be collected from all patients two or three times: 1) after you enter
the study but before you start treatment, 2) at 6 months, and 3) if your
cancer returns. After the study has begun, a small group of patients will
be chosen at random to give additional blood samples (about 2 teaspoons
each) at 24 months and at 30 months. Tests done on these blood samples may
help determine how octreotide affects cancer cell growth. Some blood and
tumor tissue will be stored for all patients for possible future tests.
[Please refer to the later section of this consent form called, "Consent to
Collect and Store Blood and Tumor Tissue" for more information about these
samples for special research tests.] Additional, routine blood tests are
listed in the following sections.
Year 1: A physical exam and blood tests requiring about 2 tablespoons of
blood will be performed at your first visit. A physical exam and additional
blood tests requiring 1-2 tablespoons of blood will be performed at 3, 6,
and 9 weeks, and at 3, 6, 9*, and 12 months after treatment starts (*blood
will not be collected at the 9-month visit). If you are receiving
chemotherapy, and if rHu G-CSF is required, additional blood tests will be
done to check the effect of the rHu G-CSF on your blood. At the end of the
Year 1, you must have a pelvic exam, a mammogram, and an ultrasound test of
the gallbladder. A chest X ray and/or a bone scan is required only if your
symptoms indicate they are necessary.
Year 2: A physical exam will be performed every 3 months. Blood tests
requiring about 1-2 tablespoons of blood will be performed at 18 months and
24 months after you begin your treatments. At the end of Year 2, you must
have a pelvic exam, a mammogram, and an ultrasound test of the gallbladder.
A chest X ray and/or a bone scan is required only if your symptoms indicate
they are necessary.
Years 3 - 5: A physical exam and blood tests requiring about 1
tablespoon of blood will be performed every 6 months. Every 12 months, you
must have a pelvic exam and a mammogram. A chest X ray and/or a bone scan
is required every 12 months only if your symptoms indicate they are
>From Year 6 On: Every 12 months you must have a physical exam, pelvic
exam, and a mammogram. A bone scan and/or a chest X ray is required every
12 months only if your symptoms indicate they are necessary.
ALTERNATIVE TREATMENTS: Alternative treatments for breast cancer that
has not spread to axillary lymph nodes include 1) mastectomy with or
without radiation therapy to the chest wall, or 2) lumpectomy with removal
of the lymph nodes plus radiation therapy. In addition to surgery (and, in
some cases, radiation therapy), tamoxifen with or without chemotherapy
drugs can be given. Other chemotherapy or drug combinations could be chosen
instead of the doxorubicin/cyclophosphamide therapy used in this study.
Your doctor will discuss these alternatives with you and will answer any of
You should understand that treatment with tamoxifen, and with doxorubicin
and cyclophosphamide, is available to you without your having to take part
in this study. Although other forms of octreotide are commercially
available, octreotide is not considered to be a standard treatment for
breast cancer. It should be given as treatment for breast cancer only as
part of an approved research study until more information about its safety
and effectiveness becomes available.
NEW INFORMATION: If any important new information about the study drugs
or therapies develops, or if another treatment is proven to be effective,
your doctor will tell you, and your options concerning your care will be
discussed at that time. After being told of any new information, it may be
necessary for you to sign an additional form providing your consent to
continue to take part in the study. In order for the study doctor to
provide you with new information, it is important that you keep him/her
aware of any change in your address.
COSTS AND PAYMENTS: Physical exams and lab tests (blood studies, X rays,
mammograms, and electrocardiograms) will be done at the times outlined
previously. These tests are felt to be part of good medical care. Your
doctor or his/her staff will tell you of any research-related procedures
that would not otherwise be necessary. The cost for the extra blood tests
and the gallbladder ultrasounds mentioned under "Special Studies" will be
paid for by Novartis Pharmaceuticals Corporation. Drugs (other than
octreotide) and all doctors' or hospital costs will be billed to you in the
same manner as if you were not part of this study. No other monetary
compensation will be provided.
Through Novartis Pharmaceuticals Corporation, the National Cancer Institute
(NCI) will provide octreotide free-of-charge for this study. However,
during the course of this study, if the drug is no longer supplied free to
the NCI, you may be asked to purchase subsequent doses of the drug.
CONFIDENTIALITY: Any information about you or about your treatment
obtained from this research, including your medical history, laboratory
data, and findings on physical examination, biopsy, and surgery, will be
kept confidential and will never be identified in any report. In order to
evaluate your overall health, your personal doctor(s) will be asked to
provide information concerning your medical care to the group of
researchers responsible for conducting this research study. It may also be
necessary to send samples of your tumor tissue to a central facility for
further medical review. The information included with your tissue will not
identify you by name, but rather by your study code. Your study records,
just like hospital records, may be requested by court order. When results
of a study such as this are reported in medical journals or at meetings,
the names of participants remain confidential. Authorized representatives
of the NCI, the FDA, the NSABP, and Novartis Pharmaceuticals Corporation
may examine and copy your medical records relating to this research, but
all information examined will be kept confidential.
RIGHT TO WITHDRAW: You are free to refuse to take part in the study or
to withdraw at any time for any reason. Your decision to do so will not
adversely affect your care at this institution or cause a loss of benefits
to which you might otherwise be entitled.
If you withdraw from further treatment, there may be potential adverse
effects, which would depend on your individual condition. You should
discuss these with your doctor before stopping treatment.
At any time, your doctor can withdraw you from this study because further
participation would not be in your best interest. Your doctor can stop the
treatments even if you are willing to continue.
COMPENSATION FOR ILLNESS OR INJURY: You will not be compensated for any
injury or illness resulting from your taking part in this study, but any
emergency medical treatment which may be necessary will be made available
to you at your expense. In the case of injury related to this research
study, you should contact ________________________ at
___________________________ . CONSENT TO COLLECT AND STORE BLOOD AND TUMOR
TISSUE: The NSABP would like to keep some of your blood and tumor tissue
that is not needed for your care. If you agree, the NSABP will keep the
samples in a specimen bank and they may be used in future research to learn
more about cancer and other medical problems. Researchers are trying to
learn more about cancer, such as what causes cancer, how to prevent it, how
to treat it better, and how to cure it. Causes of cancer may come from the
environment or from genetic causes. Genetic causes are causes that people
are born with and that can also affect other family members. Your cancer
may come from one or both of these causes. You may be concerned that
research about genetic causes may give information not only about yourself,
but also about your relatives and other groups of people who are like you.
If the NSABP agrees to let researchers do genetic testing on samples from
the bank, the testing will only be done with coded samples so that the
patient's identity is unknown. Because the value of the research is not
known at this time, and the researcher will not know who you are, your
results will not be given to you or your doctor. Even if the research that
is done on your blood and/or tissue cannot be used to help you, it might
help other people who have cancer or other medical problems.
The NSABP will be responsible for making sure your samples and information
are protected and kept confidential in the specimen bank. Your samples will
be given a code number to protect your identity. The samples will only be
given to researchers approved by the NSABP. The research study must also be
approved by an Institutional Review Board (IRB). [An IRB is a group of
people who are charged with looking after the rights and welfare of people
taking part in the research.]
The choice to let the NSABP keep your blood and tissue for doing research
is up to you. No matter what you decide to do, it will not affect your
care. If you decide that your blood and tissue can be kept for research but
you later change your mind and tell your doctor, the specimen bank will
then destroy any of your samples that they still have. Otherwise, the blood
and tissue may be kept until they are used up, or until the NSABP decides
to destroy them.
The people who use your samples to do research may need to know more about
your health both before and after your surgery. If researchers ask for
reports about your health, the NSABP will make every effort to keep them or
anyone else from getting your name, address, or phone number (unless you
are willing to be contacted in the future to take part in more research).
Although every effort will be made to keep your information confidential,
there may be an unforeseen risk that an unauthorized person may review your
information. There are laws that require that research records that have
your name on them may be shown to people who make sure that the research is
being done correctly. As mentioned before in this consent form, the NSABP,
the NCI, and the FDA will be allowed to review and copy your medical
records related to this research.
Your blood and/or tissue will be used only for research and will not be
sold. Some new products might be made because of the results of the
research that uses your samples. These products might be sold sometime in
the future, but you will not get paid. There will be no cost to you for any
specimens collected and stored in the NSABP specimen storage bank.
Please review statements 1, 2, 3, and 4 and then circle the answer that is
right for you. If you have questions, please talk to your doctor or nurse.
1. I have been told that my samples will be coded and my identity will
not be disclosed to anyone without my permission, except when required by
2. I agree that remaining blood and tumor tissue may be kept by the NSABP
for use in future research to learn about, prevent, treat, or cure cancer.
3. I agree that my blood and tumor tissue may be used for research to
answer other medical questions that are not necessarily related to cancer.
4. I agree that my doctor (or someone he/she chooses) may contact me in
the future to ask me to take part in more research.
You have been told that alternate treatments may be available. You further
have been told that the treatment you are receiving is an attempt to give
you at least as good a chance of response as is available to you by
alternate treatments for your cancer. The possible benefits to you might be
an increased duration of disease control and prolongation of life. You have
been told that the therapy can be discontinued at the discretion of the
health care providers if they deem it necessary or appropriate.
You have been told that you will receive no payment for your participation.
In the event of physical injury resulting from the research procedures,
emergency medical treatment, continuing medical care, and/or
hospitalization will not be provided free of charge nor will financial
compensation be available.
As part of the evaluation of this new treatment, you will be asked to
regularly submit blood samples and undergo regular physical examination and
x-ray studies. Almost all of these studies are routinely obtained as part
of the general follow-up and surveillance of patients, and are not part of
the investigational aspect of this study. You have been told that costs
related to your medical care including laboratory tests, radiology
procedures, and medications that may be specifically required by this
clinical research study shall be your responsibility unless specified. You
have been given the opportunity to discuss the expenses or costs associated
with your participation in this research activity.
The doctor(s) involved with your care is available to answer any questions
about the research/drug program. In case of a problem or an emergency, you
may reach Dr. ________________ at _______________ (office) or at
Should you have any questions regarding your rights as a patient, you may
call the institutional review board at (816) 276-7834.
You have been told that participation is voluntary and that you have the
right to refuse to continue if you so desire without any fear of prejudice
to additional treatment.
Your participation in the study and medical records will remain
confidential to the extent protected by law. However, your identity and
medical records will be made available upon request to the physicians and
other staff members within the Kansas City Clinical Oncology Program, the
National Cancer Institute, the manufacturer of the drug(s), the central
laboratory (if applicable), the research base, and the FDA during and after
conclusion of your participation in the study to evaluate and follow up the
results of the study. Your signature below authorizes the release of your
medical records to the above-identified groups and individuals. These
groups and individuals will maintain the confidentiality of any information
they acquire. In special circumstances, the FDA might be required to reveal
the names of the participants. Any publication of the study results will
not include any identifying information about you.
By signing this form you authorize KCCOP to access and obtain information
that is required for the study. This may include your medical records,
labs, radiologic films and reports, and pathology specimens.
Before giving your consent by signing this document, the nature and
purpose, procedures, risks and benefits of this research study, and any
alternative treatments have been explained to you. You have been given the
opportunity to review this document and ask questions, which have been
answered to your satisfaction. You understand you will be given a signed
copy of this consent form. You are consenting voluntarily to participate in
this research study and to the disclosure of your medical records as
described above. This authorization to disclose your medical records shall
not expire, even upon your death, unless specifically revoked in writing by
Signature of Patient/Subject
Signature of Non Investigator
Signature of Investigator
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