Clinical trials are essential research studies involving human volunteers that help answer specific medical questions about breast cancer prevention, diagnosis, and treatment. Each trial is categorized into four phases, focusing on safety, efficacy, and potential side effects of new treatments. While offering benefits like access to innovative therapies, trials also carry risks, and contributions are vital for advancing research and improving future patient outcomes.

1. The
basics
of
clinical
trials
10
October
2014

2. What
is
a
clinical
trial?
A
clinical
trial
is
a
research
study,
relying
upon
human
volunteers,
that
allows
scien7sts
to
inves7gate
and
answer
specific
medical
ques7ons
Yesterday’s
research
leads
to
today’s
treatments
and
tomorrow’s
cures.

3. What
do
trials
accomplish?
Trials
test
new
ways
to…
¢ Prevent
breast
cancer
¢ Diagnose
breast
cancer
¢ Treat
or
cure
breast
cancer
¢ Improve
quality
of
life
during
and
aAer
treatment

4. What
do
clinical
trial
“phases”
mean?
Each
clinical
trial
is
classified
into
one
of
4
phases,
depending
on
what
it
is
tesEng:
• Ensuring
safety
• IdenEfying
side
effects
• Confirming
dosage
• Further
evaluaEng
safety
• TesEng
effecEveness
of
a
treatment
• Confirming
effecEveness
• Comparing
to
current
standard
treatments
• Monitoring
side
effects
• Monitoring
long
term
effects
• IdenEfying
new
uses
of
the
treatment
Phase
1
Phase
2
Phase
3
Phase
4

5. The
doctor
(Principal
Inves7gator,
or
PI)
in
charge
of
the
trial
is
responsible
for
a
trial
protocol
which
includes:
¢ Why
the
trial
is
required
¢ Who
is
eligible
to
par7cipate
¢ How
many
pa7ents
are
needed
¢ What
drugs,
if
any,
will
be
given;
how
much
and
when
¢ What
tests
will
be
done,
and
when
¢ What
pa7ent
informa7on
will
be
collected
How
is
a
trial
defined?

6. What
happens
next?
¢ Poten7ally
eligible
pa7ents
are
iden7fied
¢ They
receive
detailed
informa7on
from
their
doctors
about
the
trial
¢ They
are
asked
to
sign
an
“Informed
Consent”
form
to
show
that
they
have
been
properly
informed
about
the
study

7. How
are
paEents
recruited?
¢ Pa7ents
are
chosen
based
on
factors
including
age,
gender,
type
and
stage
of
breast
cancer,
treatment
history
and
other
medical
condi7ons
¢ Some7mes
pa7ents
must
be
recruited
from
many
countries
in
order
to
ensure
that
enough
people
will
par7cipate
so
that
the
study
will
have
sta7s7cal
validity

8. Do
all
paEents
receive
the
same
treatment?
¢ All
Phase
3
trials
(and
some
in
Phase
2)
use
randomiza7on
by
computer
to
put
pa7ents
into
groups
receiving
different
treatments
¢ One
group
(the
control
group)
receives
the
current
standard
of
care
¢ One
or
more
groups
receive
the
therapy
being
tested,
some7mes
in
different
combina7ons

9. How
long
does
a
trial
last?
¢ Researchers
monitor
pa7ents
for
weeks,
months
or
years,
depending
on
the
trial
protocol
¢ Some
trials
follow
pa7ents
for
more
than
10
years,
for
example
to
track
long-­‐term
pa7ent
safety

10. The
typical
life
of
a
trial
Recruitment
Study
Interim
Results
Follow-­‐up
Review
Protocol
Final
Results
6
months
–
10
years
6
months
–
5
years
6
months
–
10
years
EnEre
duraEon
of
trial

11. What
are
the
risks
and
benefits
of
parEcipaEng
in
a
trial?
Benefits
include:
¢ Access
to
promising
new
treatments
not
available
outside
the
trial
¢ More
individualized
medical
aXen7on,
such
as
addi7onal
tests
and
check-­‐ups
¢ Contribu7on
to
improved
treatments
for
future
pa7ents
Risks
include:
¢ Experimental
treatment
could
prove
ineffec7ve
¢ Treatment
side
effects
¢ Addi7onal
7me
required
at
the
hospital
for
tests
and
check-­‐ups

12. Why
support
clinical
trials?
¢ Clinical
trials
provide
us
with
the
knowledge
we
need
to
treat
breast
cancer
beXer
¢ Now
is
the
7me
for
scien7sts
to
make
significant
progress
in
answering
ques7ons
about
how
to
treat
and
cure
breast
cancer

13. Support
trials
and
enable
progress
towards
a
cure
for
breast
cancer
Today’s
donaEons
support
tomorrow’s
trials
and
future
cures.

14. Sources
For
more
informaEon:
www.bigagainstbreastcancer.org
www.breastcancertrials.org
www.breastcancer.org/treatment/clinical_trials
www.cancer.gov/clinicaltrials
www.cancer.org/treatment/treatmentsandsideeffects/clinicaltrials/
www.cancerresearchuk.org/about-­‐cancer/trials/
www.clinicaltrials.gov