To believe in something not
yet proved and to underwrite it with our
lives; it is the only way we can leave the
For many people, clinical trials
are unknown, mysterious and perhaps even
somewhat intimidating. This may be because
information about people who participate
in clinical trials is kept strictly private.
Furthermore, it often takes many years and
many participants before the results of any
clinical trial are presented. The most important
reason many patients do not know about clinical
trials may be that some doctors do not routinely
tell their patients about clinical trials
or do not suggest ones that may be appropriate
Clinical trials are the best
way to find new ways to detect, treat and
hopefully cure breast cancer.
ways to treat breast cancer patients were
developed mainly from information gained
in clinical trials. When you receive treatment
for breast cancer, you are benefiting from
the willingness of thousands of women to
volunteer for clinical trials or other
high-quality research studies. Currently,
only about 3 percent of adult cancer patients
participate in clinical trials. If more people
took part in clinical trials, breakthroughs
in breast cancer prevention, diagnosis, treatment
and quality of life would happen faster.
Studies show that breast cancer
patients who take part in clinical trials
tend to do better than those who do not.
This may be because clinical trial patients
are given excellent care and follow-up, no
matter what treatment they get. Also, hospitals
that do clinical trials have access to state-of-the-art
equipment and follow precise guidelines
when giving treatment.
If you have had one
or more kinds of treatment, you may still
be eligible for certain clinical trials.
Some clinical trials test new follow-up
treatments that may help prevent your cancer
from returning. Others test “second-line” or “third-line” treatments
if your first treatment did not work.
the following section we attempt to take
some of the mystery out of clinical trials,
explain who can participate, and how to
find a clinical trial.
Clinical Trials Before Treatment
may want to consider clinical trials
before you get any treatment. Many
treatment trials will only take patients
who have not yet been treated for their
condition (no surgery, chemotherapy,
However, don’t delay
treatment if waiting could be harmful
to you. Talk to your doctor about how
quickly you will need treatment.
are clinical trials?
are research studies that are carefully
regulated and controlled. Clinical trials
are used to find out if new treatments
work better, the same, or worse than
the usual treatment for the same disease.
Sometimes they also look at prevention,
screening or quality of life issues.
Carefully run clinical trials are the
fastest and safest way to find treatments
that work. Many drugs which have been
tested in clinical trials are now in
common use, such as tamoxifen for breast
Before using any new
treatment with patients, scientists perform
studies on laboratory animals to find new
drugs that are most likely to work well
and be safe. If these studies, called “pre-clinical
promising, then the drug can be tested
in people in a clinical trial.
clinical trials designed?
trials of new treatments happen in three
steps, called “phases.”
I trials are
the first studies of treatment
in humans. Researchers test the
treatment on a small group of people,
sometimes just a dozen. The trial
looks at how a new drug should
be given, how often, and what dose
Phase II trials build on the knowledge gained
from a Phase I trial. The new treatment is
given to a larger group of people. This trial
continues to test the safety of the drug,
and to find out if the new treatment works
against a specific cancer.
Phase III trials build
on Phase I and II trials. The new treatment
is given to an even larger group of people.
These trials test the new drug or procedure
in comparison to the current standard.
This is usually done by assigning patients
to the new group or to the standard group
at random (“randomization”).
Patients cannot choose which group they will
To Ask Your Healthcare Team Before
Participating In A Clinical Trial
- What is the
purpose of the study?
- Who is going
to be in the study?
- What is the phase
of this clinical trial?
- Why do researchers
believe the new treatment being tested
may be effective? Has it been tested
- What kinds of tests
and treatments are involved?
- How do the possible
risks, side effects and benefits in the study
compare with my current treatment?
- How might this trial
affect my daily life?
- How long will the
- Will hospitalization
- Who will pay for
- Will I be reimbursed
for other expenses?
- What type of long-term
follow-up care is part of this study?
- How will
I know that the treatment is working? Will results of the trials
be provided to me?
- Who will be in charge
of my care?
An Introduction to Clinical Trials,
National Library of Medicine, www.clinicaltrials.gov
do clinical trials mean for breast cancer
patients and survivors?
For breast cancer patients, participating
in a clinical trial could mean:
- studying new drugs
(chemotherapy, hormonal therapy, biologic
therapies or some complementary or alternative
- studying current drugs
(testing aspects such as dosage amount
or frequency to increase effectiveness
or decrease side effects);
- studying new
surgical methods (i.e., sentinel node
- comparing surgical methods
(i.e., lumpectomy vs. mastectomy);
new equipment or devices (i.e., digital
mammography vs. traditional mammography);
care studies (better ways to manage side
effects and relieve pain, help patients
cope emotionally, or improve quality of
life and well-being in other ways); or
- prevention and early detection
thinking about clinical trials. What are
my first steps?
Talk with your doctor. Your primary care
doctor, oncologist (cancer doctor), or
surgeon, or other healthcare provider
may know about a clinical trial for you to
consider. They can help you decide whether
a clinical trial may be a good option
You do not always need a referral
from your doctor to join a clinical trial.
If you are eligible to join a trial,
the final decision is up to you. However,
you should consider the professional
opinion of your doctor. He or she may
have specific reasons why a particular
trial would not be helpful to you.
your doctor does not discuss clinical trials
with you, you can find one by calling the
National Cancer Institute (NCI) or looking
on the Internet (See the Resources at the
end of this chapter). Before you begin
looking for a trial, you will need to know
the details about your diagnosis (size and
type of tumor, location, stage, etc.) to
figure out if you qualify for a clinical
trial. Your doctor, nurse or social worker
can help you with this.
Why should I join
a clinical trial?
Clinical trials offer breast cancer
patients and survivors a number of
reasons to consider joining:
may be the best way to be sure you
get good treatment. Studies have
shown that just being in a clinical trial
(no matter what treatment group)
increased patients’ chances
- You may get a promising,
new treatment earlier. Or, you may have
a chance of treating your breast cancer
if standard treatments have not worked.
- Clinical trials
are the best way to find new treatments for breast
cancer and, hopefully, one day find a cure for the
disease. The more patients who
join clinical trials, the more quickly research moves forward
and helps other women who develop
breast cancer in the future.
- You can play an active
role in your own health care by providing
input to physicians about side effects
and quality of care.
Trials And Second Opinions
In some cases,
your doctor may be reluctant to discuss
clinical trials as a treatment option
for you. Some doctors are not familiar
with clinical trials. Others are cautious
about turning your care over to another
medical team, or are wary of the
extra time that a clinical trial
might require of them and their staff.
If this is the case, you may wish
to get a second opinion about your
treatment options and clinical trials
that may be available to you.
there reasons NOT to join clinical trials?
When you take part in a clinical trial, you
are followed carefully before, during and
after the study. This usually involves regular
tests and careful monitoring of how you are
feeling. You may need to go to the hospital
or research center more often. You should
ask how many extra visits may be needed,
and weigh how convenient it will be for you.
you are in a Phase I trial, not much is
known about how the drug or therapy will
behave in humans. Although you will be watched
carefully, there is a chance the treatment
may turn out to be harmful, unsafe or have
serious side effects.
In Phase II trials,
more is known about the treatment, but
there is no guarantee that it will work.
In Phase III trials, there is some evidence
that the therapy may work. However, there
is no guarantee that you will be picked to
receive the new treatment versus the standard
treatment, since patients are “randomized” (assigned
by chance) to each group. Also, you may
not know which treatment group you are
Who can participate?
In order to participate in a clinical
trial, a person must meet certain eligibility
requirements. Clinical trials have
different participation guidelines. These
requirements often include age, gender,
previous treatment history, nature of
the tumor, location of the tumor, other
medical conditions, and other factors.
If you think clinical trials may be an
option for you, find out about each trial’s
participation guidelines ahead of time.
Some clinical trials may not take patients
who have already had a certain drug or
Participation in clinical trials
is entirely voluntary and confidential.
You can choose whether or not to participate,
and you may withdraw from a study at
any time. You should not allow anyone
to pressure you into making a decision
without time to think about it.
decide to enter a clinical trial, you will
be asked to read and sign an Informed Consent
form. It explains what you will be doing
and what can happen to you in the trial.
Make sure you read through the form carefully
before you sign. Ask questions if you
do not understand any part of it. Even
if you sign the consent, you can still
withdraw from the trial at any time.
Recent Results Of Clinical Trials In
A new kind of mammography called “digital” mammo-graphy
may be better at finding breast cancer
in women under age 50, pre- or menopausal
women, and women with very dense breasts,
than regular mammography.
called Herceptin(R), combined with
chemotherapy, reduces the chance
of recurrence in certain women with
early-stage breast cancer.
with advanced breast cancer, a treatment
combined with chemotherapy, helped
patients live longer.
news releases from the National
Cancer Institute, www.cancer.gov.
can I find a clinical trial?
There are three main ways to find
clinical trials. However, no one method will
give you all the information you need about
every trial. Use all the tools you can.
your doctor or healthcare provider.
If the doctor doesn’t know of any
trials available for you, he or she will
at least know that you are interested
in finding one and can be on the lookout
for new information.
- The National Cancer
Institute (NCI) maintains a current list
of cancer clinical trials. You can call
them or look up trials on the web site
Internet is a good source for information on many clinical trials.
No single web site will list them all, so you may want
to look at more than one. See the
Resources at the end of this chapter for
web sites to find clinical trials. Be careful
to check the sponsors of the trial and
verify the credentials.
Before participating in any
clinical trials, ask your doctor for his or her opinion.
When talking to your doctor, it is helpful
to have a “protocol summary” of
the trial, which explains what will be
done in the trial, how and why, and the
locations of the trial.
Will it cost anything
to be part of a clinical trial?
Some insurance plans don’t
cover these costs once you join a trial.
Consult your health plan, if you have
one, or see “States
that Require Health Plans to Cover Patient
Care Costs in Clinical Trials” in
the Resources to see if your plan must
provide such coverage.
The trial sponsor
(which could be the National Cancer Institute,
a drug company, or some other organization)
usually pays the cost of the drug or
treatment being studied. However, you
or your insurance plan would be responsible
for paying “routine patient care
are the costs of medical care (e.g.,
doctor visits, hospital stays, X-rays
and other tests) that you would receive
whether or not you were in a clinical
North Carolina passed a bill
in 2002 that requires all health insurance
plans in North Carolina to cover the
routine medical costs of a clinical trial.
This law covers people diagnosed with
a life-threatening condition who choose
to enroll in a Phase II or III clinical
trial. Not all clinical trials may be
covered. Check beforehand with your insurance
company to make sure the clinical trials
sponsor is on its approved list. The
approved list includes:
Institutes of Health (NIH)
- NIH cooperative
group or center
- U.S. Food and Drug Administration
- Centers for Disease Control
and Prevention (CDC)
- Agency for Healthcare Research
and Quality (AHRQ)
- U.S. Department of
- U.S. Department of Veterans
Make sure you carefully read
and understand your health insurance coverage
before you begin a clinical trial. Ask questions
of your health plan provider if you
are unsure about what is covered. Also, work
closely with your doctor to complete
the paperwork he or she submits to
your health plan. If there are any problems
with coverage, the doctor may need
to send supporting materials about the new
treatment’s or procedure’s
safety, benefits and medical appropriateness.
for this section was adapted from the
National Library of Medicine’s
Clinicaltrials.gov, the National Breast
Cancer Coalition Fund’s Guide
to Quality Breast Cancer Care (www.stopbreastcancer.org/nbccf),
and National Cancer Institute publications
800.ACS.2345 or 866.228.4327 (TTY)
Provides information and services for all
forms of cancer, diagnosis, treatment and
many other topics. Educational materials
available on a wide variety of topics relating
to cancer, including clinical trials.
National Breast Cancer Coalition Fund
NBCCF publishes the excellent Guide to Quality
Breast Cancer Care, available free by calling
866.624.5307 or on www.stopbreastcancer.org/nbccf.
The Guide includes helpful information on
Cancer Information Service
One of the best resources available for cancer
patients, this government organization provides
the toll-free hotline above in English and
Spanish for questions about any type of cancer.
The web site has an excellent clinical trials
section, including how to search for a clinical
trial. To access “States That Require
Health Plans to Cover Patient Care Costs,” see
Books and More
Clinical Trials: Experimental Treatments
and How They Can Help You (Patient-Centered
by Robert K. Finn (1999). Guides cancer patients
through the clinical trials process, from
understanding clinical trials to financial
and other issues.
Cancer Patient, by Beverly Zakarian (1996). The author,
a cancer survivor, describes how to be
an advocate for one’s
cancer care. Clinical trials are covered,
explaining how trials work, describing the
risks involved with unproven drugs, and giving
Cancer Trials Help,
from the Coalition of National Cancer Cooperative
Has many resources for patients, including
a clinical trials finder called “TrialCheck”,
information about clinical trials, a patient
toolkit, questions to ask and a glossary.
This non-profit organization’s web
site includes a clinical trials finder.
Centerwatch: Clinical Trials Listing Service
Comprehensive resource on clinical trials.
Lists available clinical trials and has an
e-mail notification service that can inform
you of new clinical trials for your condition.
Clinical Trials Discussion List
This public online support group provides
information and resources to its members.
ClinicalTrials.gov, from the
National Library of Medicine
This site, a service of the National Institutes
of Health, includes a clinical trials finder
and resources to learn about clinical trials.
Provides a free, confidential, clinical trials
matching and referral service for cancer
People Living with Cancer,
from the American Society of Clinical Oncology
Site offers oncologist-approved information
on many types of cancer and treatment, side
effects, coping, clinical trials and more.