Download A Double-Blind Phase III Trial of Doxorubicin and

IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by
Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive
and High Risk Lymph Node Negative Breast Cancer
7/10/09
What is a research study?
This is a clinical trial, a type of research study. Your study doctor will explain the clinical
trial to you. Clinical trials include only those people who choose to take part. Please
take your time to make your decision. You may discuss your decision with your friends
and family. You can also discuss it with your health care team. If you have any
questions, you can ask your study doctor for a more detailed explanation.
You are being asked to take part in this study because you have breast cancer that has
been surgically removed but has features that could indicate a significant risk of
recurrence.
Why is this study being done?
The purpose of this study is to determine if adding a medication by the name of
bevacizumab to the current standard chemotherapy of cancer-reducing medications,
namely doxorubicin, cyclophosphamide and paclitaxel, reduces the risk of recurrence
(called disease-free survival) compared to standard chemotherapy alone.
Bevacizumab has been approved by the FDA (Food and Drug Administration) for use in
the chemotherapy treatment of patients with colorectal cancer. The outcome for those
patients showed improvement with the use of this drug. In this study, Bevacizumab is
considered investigational because it has not received FDA approval as yet for use in
breast cancer. However, this drug has been extensively studied in previous breast
cancer clinical trials. These studies showed improved results in patients whose breast
cancer recurred. Based on these results, it is hoped that using this medication or this
type of medication earlier in treatment of the disease may lead to better outcomes for
this group of patients.
How many people will take part in the study?
About 4,950 people will take part in this study.
What will happen if I take part in this research study?
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 study doctor.
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History and physical examination
Height and weight
11/2/07
Page 1 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
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Performance status (an overall assessment of the impact your breast cancer and
other factors have on your daily life)
Laboratory testing of blood and urine
Chest x-ray or CT scan of chest
EKG
Echocardiogram or MUGA scan
During the study:
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. They are part of
regular cancer care.
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Ongoing physical exams
Laboratory tests of blood
You will also need these tests and procedures that are part of regular cancer care.
They are being done more often because you are in this study.
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EKG
Echocardiogram or MUGA scan
Laboratory testing of urine
All patients will receive the same chemotherapy drugs called doxorubicin,
cyclophosphamide and paclitaxel. Doxorubicin and cyclophosphamide (abbreviated AC)
are administered as an infusion in your vein either once every 3 weeks (called the
classical schedule) for 4 doses or once every 2 weeks (called the dose dense schedule)
for 4 doses. Each AC infusion is considered one cycle of therapy. The choice of AC
schedule is not specified by this study. Your doctor will discuss the differences between
these two schedules with you in detail and recommend the schedule that is best for you.
Your study doctor will give you appropriate premedications to limit nausea and other
potential side effects. After these 4 treatments, you will receive a different
chemotherapy drug called paclitaxel as an infusion in your vein once a week for 12
doses, again with appropriate premedications to limit potential side effects. Each 3week period is considered one cycle. The total duration of chemotherapy is 24 weeks if
you receive classical AC, 20 weeks if you receive the dose dense AC. All treatment will
be given in a clinic or doctor’s office.
Once you and your study doctor have selected the AC schedule that is best for you, you
will be “randomized” into one of the study groups described below. Randomization
means that you will be assigned a group by chance. A computer program will assign
you to one of the study groups. It is similar to the flip of a coin. Neither you nor your
doctor can choose the group you will be in. You will have a 20% chance of being
assigned to Group A, a 40% chance of being assigned to Group B, and a 40% chance
of being assigned to Group C.
11/2/07
Page 2 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
All patients and doctors are “blinded” for the first 7 cycles of treatment (21 weeks if you
receive classical AC, 17 weeks if you receive dose dense AC). Blinded means that
neither you nor your doctor will know which treatment group you are in for the first 7
cycles. Both you and your doctor will be informed of your treatment group at the
beginning of your last cycle of paclitaxel (week 22 if you receive classical AC, week 18 if
you receive dose dense AC). Since the purpose of this study is to determine if adding
bevacizumab to the current standard chemotherapy reduces the risk of recurrence
compared to the current standard chemotherapy without bevacizumab, if you or your
doctor knew that you were receiving bevacizumab it might influence the results of this
study. In order for this study to be blinded, patients assigned to Group A will receive a
‘placebo’ infusion. A placebo is an inactive substance that has no effect on the body. In
this study, patients assigned to Group A will receive an infusion of dilute salt water that
contains no bevacizumab. Patients assigned to Group A will be monitored and followed
exactly the same as patients assigned to Groups B and C. The use of a placebo is
important to make sure we understand the potential side effects and benefits of adding
bevacizumab to standard chemotherapy. ALL patients will receive the same standard
chemotherapy drugs. Your study doctor will be able to find out your treatment
assignment (if you are receiving bevacizumab or placebo) at any time if it becomes
necessary to maintain your care.
All treatment groups:
You will also receive an infusion that either contains a study agent (called bevacizumab)
or a dilute salt solution that has no effect on the body (called a placebo) as an infusion
in your vein with each cycle of chemotherapy (total 8 doses). Bevacizumab or the
placebo will be given at the same time as the chemotherapy. Neither you nor your
doctor will know if you are receiving bevacizumab or a placebo for the first 7 cycles of
therapy (21 weeks if you receive classical AC, 17 weeks if you receive dose dense AC).
At your last cycle of therapy (week 22 if you receive classical AC, week 18 if you receive
dose dense AC), both you and your study doctor will be told if you have been receiving
placebo (assigned to Group A) or bevacizumab (assigned to Group B or C).
If you are assigned “Group A” or “Group B”
Once you have completed the 8 cycles of chemotherapy (24 weeks if you receive
classical AC, 20 weeks if you receive dose dense AC), you may be advised to receive
radiation and to take hormone therapy depending on your individual situation. Your
doctor will discuss this in detail with you.
If you are assigned to “Group C”
Once you have completed 8 cycles of chemotherapy (24 weeks if you receive classical
AC, 20 weeks if you receive dose dense AC), you will be re-registered onto Group D.
You will receive an additional 10 doses of bevacizumab following chemotherapy.
Bevacizumab will be administered as an infusion in your vein once every 3 weeks for 10
doses; each 3-week period is considered once cycle of therapy. The total duration of
treatment is 50-54 weeks (20-24 weeks with chemotherapy + bevacizumab followed by
30 weeks of bevacizumab alone). All treatment will be given in a clinic or doctor’s office.
11/2/07
Page 3 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
You may be advised to receive radiation and to take hormone therapy depending on
your individual situation. Your study doctor will discuss this in detail with you. If
recommended, radiation and hormonal therapy will be given at the same time as
bevacizumab.
An outline of the treatment plan for all treatment groups is included at the end of this
consent form.
2/23/10
How long will I be in this study?
Depending upon which treatment group you are assigned to and the schedule of AC
you receive, the total duration of treatment will be 20-24 weeks (Group A and Group B)
or 50-54 weeks (Group C/Group D). You will continue treatment as long as you are not
having side effects from the treatment. After you have finished the assigned treatment,
your doctor will ask you to visit the office for follow-up exams every 3 months for the first
two years after study entry, then every 6 months for years 3-5, and yearly for up to 15
years from study entry. An annual mammogram is requested as part of the standard
follow-up.
Can I stop being in the study?
Yes. You can decide to stop at any time. Tell your study 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 your study doctor if you are thinking about stopping so any risks
from the chemotherapy and/or bevacizumab can be evaluated by your study doctor.
Another reason to tell your study doctor that you are thinking about stopping is to
discuss what follow-up care and testing could be most helpful for you.
Your 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.
What side effects or risks can I expect from being in the study?
While on the study, you are at risk for the following side effects. Drugs used in this study
may cause some, all or none of the side effects listed. You should discuss these with
your study doctor. There may also be other side effects that we cannot predict. Other
drugs will be given to make side effects less serious and less uncomfortable. Many side
effects go away shortly after the drugs are stopped, but in some cases side effects can
be serious, long-lasting, permanent, or life-threatening. Death is rare, but possible.
Your doctor will check you closely to see if any of these side effects are occurring and
routine blood tests will be done to monitor the effects of treatment.
11/2/07
Page 4 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
Risks and side effects related to the drugs we are studying include:
Doxorubicin plus Cyclophosphamide(AC)
More Likely:
 Nausea and vomiting
 Loss of appetite
 Heartburn
 Hair loss
 Lowering of your blood cell counts that could cause infection, easy bruising and
bleeding, or anemia
 Red discoloration of urine (this is not blood in the urine)
Less Likely:
 Sores in mouth
 Tingling and redness in the hands and feet
 Change in color or loosening of fingernails and toenails
 Inflammation of damage to the skin around the IV tubing
 Bladder inflammation
 Bone or joint pain
 Cramps in the legs or back
Rare:
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Heart damage
Bevacizumab may increase the risk of heart damage
Increased risk of blood cancer called leukemia
If you receive dose dense AC: AC may lower the white blood counts and increase
your risk of infection. Typically the white blood count has returned to normal three
weeks after each AC treatment. In order to receive the AC every 2 weeks, you will
receive one of two growth factors called filgrastim (also called G-CSF or Neupogen®) or
pegfilgrastim (also called Neulasta®) to help your body produce more white blood cells.
Filgrastim is given as a shot under the skin once a day for ten days starting the day after
AC was given. Pegfilgrastim is given as a single shot under the skin the day after AC
was given. Your doctor will decide whether you will receive filgrastim or pegfilgrastim;
either growth factor can be used in this study. You should discuss this choice with your
doctor. You will not need filgrastim or pegfilgrastim after treatment with paclitaxel or
bevacizumab alone. Side effects of these growth factors are listed below:
Epirubicin
Due to a national shortage of doxorubicin we may need to substitute a very similar drug
from the same class of drugs called epirubicin. Clinical studies of epirubicin-containing
drug regimens in patients with early breast cancer have found these regimens to be
equally beneficial to the doxorubicin-containing regimens. Risks and side effects
related to the epirubicin are very similar to those caused by doxorubicin which includes:
11/2/07
Page 5 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
Epirubicin plus Cyclophosphamide (AC)
More Likely:
 Nausea and vomiting
 Heartburn
 Hair loss
 Diarrhea
 Lethargy (feeling weak and tired)
 Stoppage of menstrual cycles (periods) and hot flashes (if you are still
menstruating)
 Lowering of your blood cell counts that could cause infection, easy bruising and
bleeding, or anemia
 Red discoloration of urine (this is not blood in the urine)
Less Likely:
 Sores in mouth, gums and throat
 Loss of appetite
 Blood-shot eyes
 Flushing of the face (similar to blushing)
 Tingling and redness in the hands and feet
 Change in color or loosening of fingernails and toenails
 Inflammation of damage to the skin around the IV tubing
 Bladder inflammation
 Bone or joint pain
 Cramps in the legs or back
 Rapid or irregular heart beats
 Shortness of breath
Rare:
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Heart damage and congestive heart failure (Bevacizumab may increase the risk
of heart damage)
Increased risk of developing a blood cancer called leukemia
Filgrastim/Pegfilgrastim
More Likely:
 Pain in muscles, joints, lower back or pelvis
 Itching
Less Likely:
 Pain in arms or legs
 Fever
 Headache
 Shortness of breath
 Swelling especially in your feet or lower legs
11/2/07
Page 6 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
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Skin rash
Redness, swelling or pain at the injection site
Rare:
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Chest pain
Rapid or irregular heartbeat
Wheezing
Sores on the skin
Dizziness or feeling faint
Feeling weak
Paclitaxel
More Likely:
 Lowering of your blood cell counts that could cause infection, easy bruising and
bleeding, or anemia
 Mild to severe allergic reaction (rash, itching, wheezing, decreased blood
pressure)
 Numbness and pain of the hands and feet that sometimes worsens with additional
treatment and may not disappear after the drug is stopped
 Hair loss
 Muscle weakness and muscle loss
 Muscle and joint aches
Less Likely:
 Slowing of the heart rate
 Irregular heartbeats
 Nausea and/or vomiting
 Diarrhea
 Sores in the mouth or throat
 Fatigue
 Lightheadedness
 Headaches
 A sensation of flashing lights or spots
 Changes in kidney function tests (indicating a mild decrease in kidney function)
 A mild increase in triglyceride (blood lipid) levels
 Changes in liver enzymes
 Confusion; mood changes
 Skin irritation and swelling if the drug leaks from the vein into which it is being
injected into the surrounding skin
Rare:
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Liver damage or failure
Seizures
11/2/07
Page 7 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
Bevacizumab
Likely: (Updated 9/15/10)
 Diarrhea
 Nausea or the urge to vomit
 Vomiting
 Fatigue or tiredness
 Headache or head pain
 High blood pressure
Less Likely: (Updated 2/7/08, 11/12/08, and 9/15/10)
 Lack of enough red blood cells (called anemia)
 Fast heartbeat usually originating in an area located above the ventricles
 Feeling of spinning or whirling
 Belly pain
 Inflammation (or swelling and redness) of the large bowel (called colon)
 Constipation
 Heartburn
 Bleeding in some organ(s) of the digestive tract
 Partial or complete blockage of the small and/or large bowel: Ileus is a functional
rather than actual blockage of the bowel.
 Irritation or sores in the lining of the mouth
 Reaction that can occur during or following infusion of the drug: The reaction
may include fever, chills, rash, low blood pressure, and difficulty breathing.
 Chest pain, not heart-related
 Pain
 Allergic reaction by your body to the drug product that can occur immediately or
may be delayed: The reaction may include hives, low blood pressure, wheezing,
swelling of the throat, and difficulty breathing.
 Infection
 Infection (or collection of pus) around the rectum
 Premature opening of a wound along surgical stitches after surgery
 Increased blood level of a liver enzyme (called ALT or SGPT)
 Increased blood level of a liver or bone enzyme (alkaline phosphatase)
 Increased blood level of a liver enzyme (called AST or SGOT)
 Increased blood level of a liver pigment (called bilirubin) often a sign of liver
problems
 Increased blood level of a heart muscle protein (called troponin I) indicating
damage to the heart muscle
 Decreased number of a type of white blood cell (called neutrophil/granulocyte)
 Weight loss
 Decrease in the total number of white blood cells (called leukocytes)
 Loss of appetite
 Joint pain
11/2/07
Page 8 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
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Abnormal changes in the growth plate that may affect the growth of long bones in
very young children: This side effect appeared to be reversible after the
treatment was stopped but has not been assessed with long-term use of the
bevacizumab drug.
Muscle pain
Dizziness, sensation of lightheadedness, unsteadiness or giddiness
Fainting
Sudden decrease of kidney function
Blood in the urine
More protein leaking into the urine than usual, often a sign of kidney disease
Bleeding in the vagina
Cough
Shortness of breath
Nose bleed
Hoarseness
Stuffy nose
Itching
Skin rash
Hives
Formation of a blood clot that plugs the blood vessel: Blood clots may break
loose and travel to another place, such as the lung.
Rare, but Serious: (Updated 2/7/08 and 9/15/10)
 Damage of or clots in small blood vessels in the kidney that can cause
complications, some of which are serious including abnormal destruction of red
blood cells (called hemolysis) or platelets (or that help to clot blood) and kidney
failure
 Collection of signs and symptoms that indicate sudden heart disease in which the
heart does not get enough oxygen: Sudden symptoms such as chest pain,
shortness of breath or fainting could indicate heart disease and should be
reported right away. Signs such as abnormal EKG and blood tests can confirm
damage to the heart.
 Heart failure: Inability of the heart to adequately pump blood to supply oxygen to
the body
 Decrease in heart's ability to pump blood during the "active" phase of the
heartbeat (called systole)
 Heart attack caused by a blockage or decreased blood supply to the heart
 Irregular heartbeat resulting from an abnormality in the one of the lower
chambers of the heart (called ventricles)
 Ventricular fibrillation: Irregular heartbeat that involves the lower chambers of the
heart (called ventricles) that results in uncoordinated contraction of the heart:
This may be life-threatening and potentially fatal and needs immediate attention.
 Gastrointestinal fistula: An abnormal hole between an organ of the digestive
tract and another organ or tissue.
11/2/07
Page 9 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
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Gastrointestinal perforation: A tear or hole in the stomach or gut that can lead to
serious complications and may require surgery to repair.
Sore (or ulcer) somewhere in the digestive tract
Serious, life-threatening allergic reaction requiring immediate medical treatment
by your doctor: The reaction may include extremely low blood pressure, swelling
of the throat, difficulty breathing, and loss of consciousness.
Leakage from stomach due to breakdown of an anastomosis (or surgical
connection of two separate body structures)
Bleeding in the brain
Stroke caused by decreased blood flow to the brain
Abnormal changes in the brain that can cause a collection of symptoms including
headache, confusion, seizures, and vision loss associated with MRI imaging
findings. This is known as Reversible Posterior Leukoencephalopathy Syndrome
(called RPLS) and is a stroke-like condition.
A condition in which the kidneys leak a large amount of protein into the urine that
can cause complications including swelling and kidney failure
Kidney failure
Abnormal hole between part of the urinary system and another organ or tissue
Abnormal hole between the vagina and another organ or tissue
Abnormal hole between the lower breathing tube and the body cavity that
surrounds the lungs
Bleeding from the lungs
Hole in the wall that separates the nostrils of the nose
Abnormal hole between the breathing tube (called windpipe) and the tube that
goes from mouth to stomach through which food passes (called esophagus):
This is life-threatening and potentially fatal.
Blockage or narrowing of a blood vessel (called artery) that can cause damage or
loss of function including a heart attack or stroke
12/18/09
When this research study was developed, there was concern from other research
studies that treatment with standard chemotherapy and bevacizumab might
increase the risk of having congestive heart failure. Symptoms of congestive
heart failure include leg swelling and shortness of breath, which can make it
difficult to be active.
12/18/09
As part of a safety review for E5103, six of the first 200 participants treated with
chemotherapy and bevacizumab were found to develop congestive heart failure.
12/18/09
We know that congestive heart failure is a side effect of some chemotherapy
drugs used in the treatment of breast cancer. The risk of congestive heart failure
for participants in E5103 will continue to be monitored. Any new information that
can affect your decision to remain as a participant in E5103 will be brought to
your attention.
11/2/07
Page 10 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
If your tumor is sensitive to estrogen, your doctor will recommend that you receive
hormonal therapy after you complete the planned chemotherapy. (If you are in Group C,
hormonal therapy will be given concurrently with the last 10 doses of bevacizumab.)
Hormonal therapy is part of the standard treatment for estrogen sensitive tumors.
Several hormonal therapies are available, including tamoxifen, anastrozole, letrozole
and exemestane. Your study doctor will decide which is best for you based on your
individual situation. Side effects of these hormonal therapies are listed below.
Tamoxifen: Tamoxifen may cause changes in the lining of the uterus (endometrium). In
addition, in a few patients tamoxifen has been associated with an increased risk of
uterine cancer. Of course, if you have had a total hysterectomy, there is no risk of
getting uterine cancer.
Tamoxifen side effects that frequently happen are hot flushes; a feeling of being sick to
the stomach; throwing up; menstrual irregularities including vaginal discharge, bleeding,
and dryness. An infrequent side effect is abnormal occurrence of blood clots. Women
taking tamoxifen may be at a slightly higher risk for getting cataracts (a clouding of the
lens inside the eye). As women age, they are more likely to get cataracts whether or not
they take tamoxifen. Cataracts may lead to poor vision. Tamoxifen can raise sensitivity
to blood thinners such as coumadin.
Anastrozole: Common side effects (happens in greater than 5% of patients): Hot
flushes, fluid retention (swelling in legs, puffiness around the eyes, generalized), pain (in
chest, bone, and pelvic areas, in legs and joints, and at the tumor site); headache,
dizziness, depression, rash, feeling sick to the stomach, throwing up, loose stools,
abdominal pain, loss of appetite, dry mouth, muscle weakness, tingling of the arms and
leg, shortness of breath, cough, inflammation of the throat area. Less common side
effects (happens in 2-5% of the patients): High blood pressure, inflammation of the
veins, problems sleeping, confusion, anxiety, fever, nervousness, feeling out of sorts,
hair thinning, rash, breast pain, weight loss, infections (upper and lower respiratory tract
and urinary tract), loss of energy, lowered blood counts that can lead to infection and
bleeding and bruising, muscle and joint pain, neck pain, inflammation of the nose and
throat areas, flu-like symptoms, infection, possible fracture.
Letrozole: Common side effects (happens in more than 10% of patients): Hot flushes,
headache, tiredness, feeling sick to the stomach, pain (in chest, rib, and back areas, in
legs and joints, muscles, and at the tumor site), shortness of breath, cough. Less
common side effects (happens in 2-9% of patients): Chest pain, fluid retention (swelling
in legs, puffiness around the eyes, generalized), high blood pressure, problems
sleeping, dizziness, depression and anxiety, rash, loss of hair, breast pain, throwing up,
trouble passing stool, loose stools, abdominal pain, loss of appetite, weight loss or
weight gain, increase in cholesterol levels, stomach discomfort after eating. Rare side
effects (happens in less than 2% of patients): Blood clots, heart problems (heart attack,
coronary artery disease, etc.).
11/2/07
Page 11 of 24
Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
Exemestane: Common side effects (happens in more than 9% of patients): Hot flashes;
fatigue; pain (in chest, rib, and back areas, in legs and joints, and at the tumor site);
problems sleeping; depression or anxiety; difficulty with breathing; feeling sick to the
stomach; decreased number of a type of blood cell called lymphocytes, which could
increase your chance of infection. Less common side effects (happens in about 3 to 9%
of patients): Dizziness, sweating, fluid retention (swelling in legs, puffiness around the
eyes, generalized), high blood pressure, burning or prickling sensations, skin rash,
itching, flu-like symptoms, fever, coughing, infections (upper and lower respiratory tract
and urinary tract), weakness, weight gain, throwing up, loose stools, abdominal pain,
loss of appetite, increased appetite, constipation, intestinal or stomach discomfort,
headache, hair loss, confusion, decreased sensitivity to stimuli. Rare but serious side
effects may include changes in blood test results that indicate problems with liver and/or
kidney function. Exemestane causes breaks in the genetic material (DNA) of human
cells grown in the laboratory. Studies to test whether exemestane causes cancer in rats
and mice have not been completed yet, but it is known that drugs that cause breaks in
DNA sometimes cause cancer in people.
Radiation Therapy: During radiation therapy, you may get some or all of the following
side effects: Redness and irritation of the skin in the area being treated. After ending
radiation therapy, you may get none, some, or all of the following side effects: Tanning
and dryness of the skin in the treatment area, swelling of the arm, and chest or breast
discomfort. Less common side effects may be lung or heart injury, increased chance of
ribs breaking, reduced arm motion, or the start of another cancer.
11/12/08
Reproductive Risks
The impact of bevacizumab on future fertility is currently unknown. However, it is
possible that treatment with bevacizumab may impair fertility and decrease the
likelihood of becoming pregnant in the future. The drugs in this study can affect an
unborn baby. Therefore, women should not become pregnant while on this study.
Women must use a reliable method of birth control while participating in this study.
Check with your study doctor about what kind of birth control methods to use and how
long to use them. Some methods might not be approved for use in this study. Reliable
methods of birth control are considered to be: abstinence (not having sex), Intrauterine
Device (IUD), tubal ligation, hysterectomy or vasectomy of the partner (with confirmed
negative sperm counts) in a monogamous relationship (same partner). An acceptable,
although less reliable method involves the careful use of condoms and spermicidal foam
or gel and/or cervical cap or sponge. Patients should ask about counseling and more
information about preventing pregnancy. Patients who feel they might be pregnant,
even though they practiced birth control, must notify the study doctor immediately. A
pregnancy test may be performed.
Women should not breastfeed a baby while on this study. Pregnant women and nursing
mothers are excluded from participation in this study. If a woman becomes pregnant,
she will be withdrawn from the study.
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IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
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If you are able to become pregnant, a blood test will be performed within 7 days of
randomization to insure you are not pregnant. Also, bevacizumab remains in your body
for weeks to months, you should continue to use adequate contraceptive measures and
avoid nursing a baby for at least 3-4 months after your last dose of bevacizumab,
although the exact duration of bevacizumab remaining in the body is not predictable for
each individual patient. If you have any questions about these issues, or have
questions about preventing pregnancy, please discuss them with your doctor.
For more information about risks and side effects, ask the researcher or nurse.
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
adding bevacizumab to standard chemotherapy will be more useful against cancer
compared to the usual treatment, there is no proof of this yet. We do know that the
information from this study will help doctors learn more about adding bevacizumab to
standard chemotherapy as a treatment for cancer. This information could help future
cancer patients.
What other choices do I have if I do not take part in this study?
Your other choices may include:
 Getting treatment or care for your cancer without being in a study
 Taking part in another study
 Getting no treatment
Talk to your doctor about your choices before you decide if you will take part in this
study.
Will my medical information be kept private?
The Eastern Cooperative Oncology Group (ECOG) is conducting this study. ECOG is a
cancer research group that conducts studies for the National Cancer Institute. Your
doctor is a member of ECOG or another group that is participating in this study. To help
protect your privacy, ECOG has obtained a Confidentiality Certificate from the
Department of Health and Human Services (DHHS).
With this Certificate, ECOG cannot be forced (for example, by court subpoena) to
disclose information that may identify you in any federal, state or local civil, criminal,
administrative, legislative or other proceeding. Disclosure will be necessary, however,
upon request of DHHS for audit or program evaluation purposes.
You should know that a Confidentiality Certificate does not prevent you or a member of
your family from voluntarily releasing information about you or your involvement in this
research. If an insurer or employer learns about your participation and obtains your
consent to receive research information, then ECOG may not use the Certificate of
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IRB Approval Date _____________
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Broadcast: 1/7/11
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Confidentiality to withhold this information. This means that you and your family must
also actively protect your privacy.
You should also understand that your doctor and ECOG may take steps, including
reporting to authorities, to prevent you from seriously harming yourself or others.
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.
10/2/09
A record of your progress will be kept in a confidential form at your hospital or doctor’s
office where you receive treatment. Organizations that may inspect and/or copy your
research and medical records (blood samples, x-rays, scans, pathology slides, etc.) for
quality assurance, research, and data analysis include groups such as:
Southeast Cancer Control Consortium (SCCC) Operations Office
Cancer Trials Support Unit (CTSU) and its representatives
Eastern Cooperative Oncology Group (ECOG)
Central laboratories, banks and/or reviewers
National Cancer Institute (NCI) and its representatives
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
A qualified representative of applicable drug manufacturers
Possible other federal or state government agencies
ECOG Data Safety Monitoring Board (DSMB), an independent group of
researchers who review the conduct of the trial
Dana Farber Institute (DFCI)
If your record is used or given out for governmental purposes, it will be done under
conditions that will protect your privacy to the fullest extent possible consistent with laws
relating to public disclosure of information and law-enforcement responsibilities of the
agency. These agencies may review the research to see that it is being done safely
and correctly.
You authorize the use of clinical information contained in your records, but any
publication which includes such information or data shall not reveal your name, show
your picture or contain any other personally identifying information, except as otherwise
required by law.
What are the costs of taking part in this study?
You and/or your health plan/insurance provider (Medicare should be considered a
health insurance provider) 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 people taking part in
studies. Check with your health plan or insurance company to find out what they will
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IRB Approval Date _____________
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Broadcast: 1/7/11
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Southeast Cancer Control Consortium Consent Form
pay for. Taking part in this study may or may not cost your insurance company more
than the cost of getting regular cancer treatment. You or your insurance carrier will be
responsible for the costs of clinic visits, any hospital admissions, laboratory tests,
x-rays, scans, chemotherapy treatments, radiation treatments, and any other tests.
Please ask your doctor about any added costs or insurance problems.
The Division of Cancer Treatment and Diagnosis, NCI, will provide you with the
investigational agent, bevacizumab, free of charge to all participants. If bevacizumab
becomes commercially available for this indication, there is a remote possibility that you
may be asked to purchase subsequent supplies. Your doctor will discuss this with you
should this situation arise.
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.
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.
You will not be paid to participate 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, _________________________ 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 #____________________________.
You will get medical treatment if you are injured as a result of taking part in this study.
You and/or your health plan will be charged for this treatment. The study will not pay for
medical treatment. Although no funds or monies have been set aside to compensate
you in the event of injury or illness related to the study treatment or procedures, you do
not waive any of your legal rights for compensation by signing this form.
You or your insurance company will be charged for continuing medical care and/or
hospitalization.
What are my rights if I take part in this study?
Taking part in this study is voluntary. You may choose to take part, not to take part, or
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 or result in any penalty or loss of benefits to which you are
entitled.
Even after you agree to take part in this study, you may withdraw at any time. Before
you withdraw, you should talk to one of the researchers or nurses involved. This will
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IRB Approval Date _____________
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Broadcast: 1/7/11
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Southeast Cancer Control Consortium Consent Form
allow them to inform you of any medical problems that could result from stopping your
treatment. You can choose to withdraw one of two ways. In the first, you can stop your
study treatment, but still allow the study doctor to follow your care. In the second, you
can stop your study treatment and not have any further contact with the study staff.
Either way, there will be no penalty to you. Your decision will not affect your medical
treatment or your relationship with those treating you or with this institution. If you
withdraw from the study, you will still be offered all available care that suits your needs
and medical condition. You are free to seek care from a doctor of your choice at any
time.
A Data Safety and Monitoring Committee (DSMC), an independent group of experts, will
be reviewing the data from this research throughout the study. The DSMC is a
committee assigned to a randomized clinical trial charged or obligated with the
responsibility of monitoring performance of the trial, safety of the participants, and
effectiveness of the treatments being tested.
7/10/09
Arrangements have been made to reimburse institutions for non-standard of care
MUGA/ECHO scans, EKG, and urine protein studies.
We will tell you about new information that may affect your health, welfare or willingness
to stay in this study. You may be asked to sign another consent form in response to
new information.
Who can answer my questions about the study?
For questions about the study or a research-related injury, contact your doctor,
_________________, at # _____________________. You may ask your doctor for
further information on the risks, benefits or alternative treatments.
For questions about your rights as a research participant, contact the
___________________ Institutional Review Board (which is a group of people at the
hospital in the community where you receive treatment who review the research to
protect your rights) at # __________________ (the office of _____________________).
Please note: This section of the informed consent form is about additional
research studies that are 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 each of the following studies. Please mark your
choice for each study.
10/2/09
Laboratory Research Studies
This study includes one or more laboratory tests that will analyze a small sample of
blood. Blood will be collected using a needle. The risks of a blood draw may include
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IRB Approval Date _____________
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Broadcast: 1/7/11
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Southeast Cancer Control Consortium Consent Form
pain, bruising, and/or infection at the site of injection. In order to minimize these risks,
your blood will be drawn by an experienced technician or other clinician. The blood
collection will be done at the same time as blood is drawn for your routine care. The
blood for this study will be sent to a laboratory, where tests will be performed.
Researchers will look at differences in certain proteins and genes (DNA). Researchers
will look for genes affecting how patients are affected by or process the drugs used in
your treatment. Also, researchers will look for genes that may predict response to the
study drugs. The results from these tests will not be sent to you or your doctor, and they
will not be used in planning your care. These tests are only for research purposes.
Some data from these studies will be provided to a government health research
database for broad sharing to approved researchers. This information will be deidentified and will not contain any traditional identifiers (for example: your name, date of
birth, address, and telephone number). There is a slight risk that there could be a
breach in the security of this database system resulting in the access of information.
Safeguards are in place to minimize this risk.
A possible risk from your participation in this phase of the study involves loss of privacy
as a result of providing genetic material (DNA) for research. Although your genetic
information is unique to you, you do share some genetic information with your children,
parents, brothers, sisters, and other blood relatives. Consequently, it may be possible
that genetic information from them could be used to help identify you. Similarly, it may
be possible that genetic information from you could be used to help identify them. While
information traditionally used to identify you will not be released to anyone (for example:
your name, date of birth, address, and telephone number), people may develop ways in
the future that would allow someone to link your genetic or medical information back to
you.
There also may be other privacy risks that we have not foreseen.
Making Your Choice
Please read the sentence below and think about your choice. After reading the
sentence, circle “Yes” or “No.” No matter what you decide to do, it will not affect your
care. You can participate in the treatment part of the study without participating in the
research studies. If you have any questions, please talk to your doctor or nurse, or call
our research review board at # _________________________.
I agree to participate in the laboratory research studies that are being done as
part of this clinical trial.
Yes
No
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Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
7/10/09
Will Any of the Samples (e.g., Tissue) Taken from Me Be Used for Other Research
Studies?
We would like to have some of the tissue that was collected from your original
diagnostic biopsy or surgery and collect a small amount of your blood to use for future
research. If you agree, this tissue and blood will be kept and may be used in research to
learn more about cancer and other diseases. Tissue and blood samples are often called
“biological specimens” or more simply, “specimens.”
7/10/09
These specimens will be given only to researchers approved by the Eastern
Cooperative Oncology Group (ECOG) and the National Cancer Institute (NCI). The
researcher’s Institutional Review Board will approve any research done on the
specimens. The research that may be done with your specimens will probably not help
you. It might help people who have cancer and other diseases in the future.
Reports about the research done with your specimens 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 specimens 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
the Eastern Cooperative Oncology Group study.
If you decide now that your specimens can be kept for research, you can change your
mind at any time. Just contact your study doctor and let him or her know that you do not
want us to use your specimens for research, and any remaining tissue or blood will no
longer be used. However, information already obtained from your donated specimen
samples at the time of your request will continue to be used by researchers.
In the future, people who do research may need to know more about your health. When
the Eastern Cooperative Oncology Group gives reports about your health, it will not give
out your name.
10/2/09
Sometimes specimens are used for genetic research (about diseases that are passed
on in families). Even if your specimens are used for this kind of research, the results will
not be put into your health records.
Your specimens will be used only for research, and will not be sold. You will not be paid
for allowing your leftover specimens to be used in research, even though the research
done with your specimens may help to develop new products in the future. Similarly,
there will be no cost to you for any specimens collected and stored by the Eastern
Cooperative Oncology Group.
The specimens will be stored indefinitely.
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Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
7/10/09
Will personal information be associated with the specimens?
Your specimens sent to research laboratories and repositories will have some
identifying information, such as initials and where the specimens were collected. To
protect your identity, your specimens and any related information will receive a unique
identification code. Researchers approved to use the specimens for future research will
only receive the code that is attached to your specimen. Any information from your
research records that is approved to go to a researcher will also receive a code.
Any research or information that is published, presented at scientific meetings or made
public in any other way will use only coded information.
7/09,10/09 What
are the risks of giving specimens for research?
Loss of privacy and confidentiality of information
The greatest risk to you is the improper release or misuse of your information and
specimens. The chance of this happening is very small. We have many protections in
place to lessen this risk. These protections are described under the heading, “How will
the information related to your specimens be protected?”
Risk from genetic research
Genetic research may find medical conditions that affect you and your blood relatives
since it looks at inherited traits. While your genes are unique to you, you share some of
them with your blood relatives. It is possible that genetic research may find potential
health concerns for you or your family. While this situation is rare, information could be
misused by employers, insurance companies, and others. For example, life insurance
companies may charge a higher rate based on this information.
There is a national effort to share genetic testing results and related information among
researchers. If this type of testing is done with your specimens in the future, coded data
would probably be sent to a central database kept by the NCI. The NCI would
determine which researchers may look in this database.
We believe that the risks to you and your family from genetic research are very low.
Some states have laws that help to protect against genetic discrimination. A recent
federal law (Genetic Information Non-Discrimination Act, GINA) will help reduce the risk
from health insurance or employment discrimination. The law does not include other
types of misuse by life insurance or long term care insurance. If you want to learn more
about the GINA Law, you can find information about it on the internet or ask the study
staff.
While we believe that the risks to you and your family are very low, we cannot tell you
exactly what all of the risks are from taking part in genetic research studies. Your
privacy and confidentiality will be protected to the fullest extent possible.
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Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
7/10/09
HOW WILL INFORMATION RELATED TO YOUR SPECIMENS BE PROTECTED?
We have many ways to protect the information related to your specimens:
1.
Your specimens and information receive a unique code. Researchers only receive
coded specimens and information, and will not be able to see the key that links the
code to you. Only approved people in ECOG can match you to the code on your
specimens and related information.
2.
Strict security safeguards are in place to reduce the chance of misuse or
unplanned release of information. Steps we take include password protected
access to databases and keeping freezers that contain specimens in a locked
area.
3.
Research studies are reviewed for the quality of the science and for patient
protection before specimens are given to researchers. To make sure the research
follows the rules of ECOG and state or federal laws, records from research studies
can be reviewed by ECOG, by the sponsor, and by government agencies.
4.
Rules for publications: If research results are published, you will not be identified
by name or any other personally identifiable information.
5.
ECOG also has a Certificate of Confidentiality from the U.S. Department of Health
and Human Services. The Certificate protects against the forced release of
personal information from the specimen bank or database. What this means is
that ECOG cannot be forced to disclose your identity to any third party. It is
possible that for some criminal proceedings, the Certificate of Confidentiality could
be over-ridden.
7/10/09
Benefits
The research that may be done with your specimens will probably not benefit you
directly. It may help researchers learn more about what causes cancer and other
diseases, how to prevent them, and how to select the most appropriate treatment for
future patients who have these diseases.
7/10/09
Changing your mind about letting us use your specimens
If at any time you decide you no longer want your specimens used for research, please
give your doctor or study nurse a signed note stating your decision. They will contact
ECOG and tell us about your decision.
If your specimens were already sent from the repository and are being used for a
project when you withdraw your consent, your specimens and accompanying data will
still be used for that approved project. Once you choose to end your participation, no
further specimens or related information will be sent to researchers from the repository
for any new research projects.
Specimens will NOT be returned to you. Depending on the type of specimen, it will be
marked as not for research use or destroyed.
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Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
7/10/09
Voluntary Participation
The choice to participate in the optional laboratory research projects or to allow your
specimens to be stored for future research is completely up to you. No matter what
you decide to do, your decision will not affect your medical care. You can
participate in the treatment part of the study without participating in these research
projects.
Please read the research study descriptions below, review the questions carefully and
circle “Yes” or “No”. If you circle “Yes”, you are indicating you understand:






Coded information collected from your medical records may be given to
researchers to perform these studies.
The research results from your specimens will not be given to you or your doctor,
they will not be placed in your medical record and they will not affect your
medical care.
Your specimens may be used in genetic research. If they are, the coded results
and accompanying information may be shared in an NCI database.
The risks associated with allowing your specimens to be used in research,
including the possible risks associated with genetic research.
You will not receive any payment for the use of your specimens for these
projects. You or your insurance will not be billed for any of these research
studies.
That at any time, you can end your participation in the projects and any
remaining specimens or information will not be used for new research.
If you do not agree with any of the statements above, indicate “No” to ALL the questions
below.
If you have any questions, please talk to your doctor or nurse, or call the
institution’s research review board at # _______________________.
My specimens may be kept for research to learn about, prevent, treat, or cure
cancer.
Yes No
My specimens may be kept for research about other health problems (for
example, causes of diabetes, Alzheimer’s disease, and heart disease). (2/7/08)
Yes No
Someone from this institution may contact me in the future to ask me to take
part in more research. (2/7/08)
Yes No
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Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
Where can I get more information?
 You may call the National Cancer Institute’s (NCI’s) Cancer Information Service
at:
1-800-4-CANCER (1-800-422-6237) or TTY: 1-800-332-8615



You may also visit the NCI Web site at http://cancer.gov
For the NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials
For the NCI’s general information about cancer, go to:
http://cancer.gov/cancerinfo
Participant Agreement
I have been offered the opportunity to ask questions about this study and all questions
have been answered to my satisfaction. The contents of this form have been explained
to me and I understand them. I agree to allow the research personnel specified above
the access to my medical records.
It may be necessary for my doctor to contact me at a future date regarding new
information about the treatment I received; therefore I agree to notify my doctor of any
change of address and/or telephone number.
My signature below means that I have voluntarily agreed to participate in this research
study. I will be given a copy of all 24 pages of this consent. I have read it or it has been
read to me. I may also request a copy of the study (complete study plan).
______________
(Date)
_________________________________
(Participant Signature)
I certify that I have explained to the above individual the nature and purpose, the
potential benefits, and possible risks associated with participation in the research study
and have answered any questions that have been raised.
______________
(Date)
11/2/07
_________________________________
(Signature of Person Obtaining Consent)
Page 22 of 24
IRB Approval Date _____________
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Broadcast: 1/7/11
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Southeast Cancer Control Consortium Consent Form
Study Plan 1
Classical (every 3 week) AC
Choice of classical versus dose dense AC scheduling based on investigator’s discretion
Randomize
You will be assigned to a group by chance. You will have a 20% chance of being assigned to
Arm A, a 40% chance of being assigned to Arm B, and a 40% chance of being assigned to
Arm C. You will not know what group you have been assigned to (i.e. you will not know
whether you are receiving a placebo or bevacizumab).
Arm A
Doxorubicin plus
Cyclophosphamide plus
Placebo every 21 days for 4
cycles
(cycles 1-4)
Paclitaxel once every 7 days
(12 doses) plus
Placebo every 21 days
(4 doses)
(cycles 5-8)
Arm B
Arm C
Doxorubicin plus
Cyclophosphamide plus
Bevacizumab every 21 days
for 4 cycles
(cycles 1-4)
Paclitaxel once every 7 days
(12 doses) plus
Bevacizumab every 21 days
(4 doses)
(cycles 5-8)
Doxorubicin plus
Cyclophosphamide plus
Bevacizumab every 21 days
for 4 cycles
(cycles 1-4)
Paclitaxel once every 7 days
(12 doses) plus
Bevacizumab every 21 days
(4 doses)
(cycles 5-8)
You will be unblinded (i.e. you will find out whether you have been receiving a placebo or bevacizumab) at the
beginning of your last cycle of paclitaxel.
Register
Arm D
Classic AC:
1 cycle of therapy = 21 days
Bevacizumab 15 mg/kg
every 21 days x 10
(cycles 9-18)
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Participant Initials _____
IRB Approval Date _____________
Version: 1/31/11; Addendum #8
Broadcast: 1/7/11
CTSU E5103
Southeast Cancer Control Consortium Consent Form
Study Plan 2
Dose dense (every 2 week) AC
Choice of classical versus dose dense AC scheduling based on investigator’s discretion
Randomize
You will be assigned to a group by chance. You will have a 20% chance of being assigned to
Arm A, a 40% chance of being assigned to Arm B, and a 40% chance of being assigned to Arm
C. You will not know what group you have been assigned to (i.e. you will not know whether you
are receiving a placebo or bevacizumab).
Arm A
Doxorubicin plus
Cyclophosphamide plus Placebo
every 14 days for 4 cycles
(cycles 1-4)
(1/3/08)
Arm B
Doxorubicin plus
Cyclophosphamide plus
Bevacizumab every 14 days for 4
cycles
(cycles 1-4)
(1/3/08)
Arm C
Doxorubicin plus
Cyclophosphamide plus
Bevacizumab every 14 days for
4 cycles
(cycles 1-4)
Paclitaxel once every 7 days
Paclitaxel once every 7 days
Paclitaxel once every 7 days
(12 doses) plus Placebo every 21
days (4 doses)
(12 doses) plus Bevacizumab
every 21 days (4 doses)
(12 doses) plus Bevacizumab
every 21 days (4 doses)
(cycles 5-8)
(cycles 5-8)
(cycles 5-8)
You will be unblinded (i.e. you will find out whether you have been receiving a placebo or bevacizumab) at the beginning of
your last cycle of paclitaxel.
Register
Arm D
Bevacizumab 15mg/kg
every 21 days x 10
Dose Dense AC:
Cycles 1-4: 1 cycle of therapy = 14 days
Cycles 5 and beyond: 1 cycle of therapy = 21
days
11/2/07
(cycles 9-18)
Page 24 of 24
Participant Initials _____
CTSU/E5103
Southeast Cancer Control Consortium Withdrawal of Consent
I, _____________________________, withdraw my consent to participate in this study
and refuse to be followed and have clinical data collected from my medical records.
Participant Name ___________________________________ Study/ID #___________
(Please Print Name)
Participant Signature ____________________________________ Date ___________
Witness Signature ______________________________________ Date ___________
11/2/07
CTSU/E5103
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
I, _____________________________, withdraw my consent for treatment on this study.
Even though I withdraw my consent for treatment, I will continue to be followed and
clinical data will be collected from my medical records.
Participant Name ___________________________________Study/ID #____________
(Please Print Name)
Participant Signature ____________________________________
Date __________
Witness Signature ______________________________________
Date __________
11/2/07