Taking part in RxPONDER
Thank you for your interest in the
RxPONDER (riz-POND-er) clinical trial.
RxPONDER's goal is to help doctors
and their patients with breast cancer
make better treatment decisions by
using a genomic test known as the
Oncotype DX® Assay.
Patients with hormone receptor-positive
breast cancer that has spread
to their lymph nodes usually get both
chemotherapy and hormonal therapy
after surgery. But for some of
these patients with low to intermediate
"recurrence scores" on the Oncotype
DX test, chemotherapy may
offer little or no benefit. Hormonal
therapy alone may be enough.
RxPONDER will measure just how
much, if any, benefit these patients
get from chemotherapy. And it will
try to determine where the cutoff
score is between patients who benefit
from chemotherapy and patients
who do just as well with hormonal
therapy alone.
This web page does not replace the study's informed consent form or information from your study doctor.
What is a clinical trial?
A clinical trial is one of the final stages of a long and
careful cancer research process. Studies are done
with cancer patients to find out whether promising
approaches to cancer prevention, diagnosis,
and treatment are safe and effective, and to answer
questions that will improve cancer care.
What question does RxPONDER hope to
answer?
RxPONDER (also known as SWOG S1007) is designed
primarily to answer this question:
For patients with node-positive, hormone-receptor
positive, HER2 negative breast cancer who also
have low to intermediate Oncotype DX recurrence
scores, what are the benefits -- if any -- from adding
chemotherapy to hormonal therapy after surgery?
Why is it important to answer this question?
The short answer is this: So patients don't get chemotherapy
they don't need.
Patients with node-positive breast cancer generally
get chemotherapy as a standard part of their treatment
following surgery (also called adjuvant treatment).
But many of these patients see little added
benefit from that chemotherapy; for many patients,
hormonal therapy is enough.
If we can use a test to predict who will benefit from
chemotherapy and who is unlikely to benefit, we
can save some patients from the potentially serious side effects
and the cost of a course of chemotherapy treatment
they don't need.
Who can take part in the RxPONDER trial?
You may be eligible to take part in RxPONDER if
- you are a woman with early breast cancer and
have had or will have surgery,
- your cancer is hormone-receptor positive,
- your cancer is HER2-negative,
- your cancer has been found in from 1 - 3 of your lymph nodes, and
- you have not yet begun chemotherapy or hormonal
therapy for your cancer.
What will happen in the study?
If you agree to take part, some of your tissue that
was removed at surgery will be tested with the Oncotype
DX Assay. This is Step 1. If the result of that
test is a recurrence score of 25 or lower, you will be
eligible to continue with Step 2 of the study.
If your recurrence score is higher than 25, you will
be finished with your contributions to this trial.
You and your doctor will decide the best course of
treatment, and you may be able to identify other
clinical trials you can take part in.
What will happen in Step 2 of the study?
If your recurrence score is 25 or lower, you will be
placed at random into one of two study groups:
- Arm 1: treated with chemotherapy and hormonal
therapy
- Arm 2: treated with hormonal therapy
Your chance of being placed into Arm 1 is equal to
your chance of being placed into Arm 2. In each
case, that chance is fifty percent. Once you have
been "randomized," you and your doctor will be
told which study arm you have been placed in.
If you are in Arm 1:
Your doctor will first prescribe you a course of chemotherapy.
There are a number of chemotherapy
drugs and drug combinations that are considered
"standard of care" and are options in this trial. You
and your doctor will decide which chemotherapy
option is best for you.
You will then have a course of hormonal therapy
(also called endocrine therapy). This therapy might
include ovarian suppression drugs if you are premenopausal,
aromatase inhibitors if you are postmenopausal,
or drugs such as tamoxifen that block
estrogen receptors in the body. You and your doctor
will choose the hormonal therapy that is best
for you.
If you are in Arm 2:
Your doctor will prescribe you a course of hormonal
therapy only (as described in Arm 1 above). You
will not get a course of chemotherapy.
What is the Oncotype DX Breast Cancer
Assay? How is it done?
Lab researchers will examine a small sample of the
tissue that was removed during your breast cancer
surgery. They will analyze a group of 21 genes -- 16
cancer related genes and 5 control genes -- to see how
active they are, or their "expression pattern." The
results of the test will be reported as a recurrence
score between 0 and 100. Studies have shown that
the higher this recurrence score, the more likely it
is that a patient's cancer will return.
Other studies have shown that in some cases doctors
can use this recurrence score to determine how
likely it is that a patient will benefit from adding
chemotherapy to hormonal therapy. RxPONDER
should answer questions about how to use the recurrence
score in this way for patients with node-positive
breast cancer.
The Oncotype DX Breast Cancer Assay is performed
by Genomic Health, Inc. of Redwood City,
California. The test has been used to evaluate
tumors and inform treatment decisions for more
than 175,000 breast cancer patients since 2004.
What benefits will I see from participating in
this study?
You will probably not see any extra benefit from
participating in this trial. The treatments used in
both arms are among the standard regimens that
will be used to treat your type of breast cancer even
if you do not enroll in this trial.
The benefits from the trial will be realized by women who develop breast cancer in the future and who
have more targeted, effective treatment options to
prolong and improve their lives because of your
participation. You may help keep some women
from a grueling course of chemotherapy that's not
necessary. You may help ensure other women get
the chemotherapy that will prolong their lives. Just
as most of the treatments you benefit from today
were developed in clinical trials with past patients,
future patients would see the benefits of your contributions.
What are the risks of participating in the
study?
Most of the risks of participating are the risks posed
by chemotherapy and hormonal therapy. Common
side effects from chemotherapy include hair loss,
nausea or vomiting, fatigue or dizziness, tingling
or numbness in hands and feet, heightened risk of
infection, and difficulty concentrating.
Common side effects from hormonal therapy include
joint pain, increased cholesterol levels, nausea,
and menopausal symptoms such as hot flashes,
vaginal dryness, and mood swings. Both chemotherapy
and hormonal therapy can also cause infertility.
Remember that these side effects are risks from
treatment of the cancer. You are likely to encounter
them whether you participate in this study or
not. Your doctor will discuss with you the specific
risks of the course of treatment you choose.
What if I decide I would like to stop
participating?
You can leave the trial at any time. Simply tell your
doctor you plan to stop participating so he or she
can tell you how to stop safely.
Would being on this study change the cost of
my care?
Taking part in the trial probably will not significantly
change the cost of your care, but we can't say
that for sure.
The treatments and routine tests done within Rx-
PONDER are considered part of standard care for
your condition, and you or your insurance company will be billed (just as if you were not in a clinical
trial). Insurance companies and Medicare generally
cover the routine costs of care required in clinical
trials, but coverage varies from plan to plan.
The National Cancer Institute's
website has more information on clinical trials and insurance
coverage.
Will I have to pay for the Oncotype DX test?
No. The Oncotype DX Breast Cancer Assay is an
approved diagnostic test in the U.S. The cost will
be billed to your insurance company. Genomic
Health will work with insurance companies directly
to get reimbursed for the test.
If you were registered for this study before the test
was ordered, you will not be charged for the cost of
the test even if your insurance company does not
pay for all or part of it, or if you can not afford
health insurance. If you were registered for this
study after the test was ordered, Genomic Health's
normal billing policies apply.
You may receive an Explanation of Benefits (EOB)
statement from your insurance company letting
you know that a claim has been submitted on your
behalf. But you won't receive a bill from Genomic
Health for the test cost or for a deductible or co-pay
amount.
If you have questions or concerns about a statement
you get from your insurance company for the Oncotype
DX Assay or about Genomic Health's billing
policies, please call Genomic Health at 1-866-ONCOTYPE
(1-866-662-6897) toll-free.
Funding to help offset patient costs for the Oncotype
DX test is being provided through a cost-sharing
agreement between The Hope Foundation
(SWOG's philanthropic arm) and Genomic Health.
Who is conducting this clinical trial?
Most of the major National Cancer Institute (NCI)-
supported cooperative groups are collaborating to
conduct RxPONDER. The trial is designed and
coordinated by one of those groups, SWOG (formerly
the Southwest Oncology Group).
SWOG is a network of more than 4,000 cancer researchers at more than 500 institutions across the
country and beyond. Its mission is to improve the
practice of medicine in preventing, detecting, and
treating cancer and to enhance the quality of life
for cancer survivors.
Since the 1950s, more than 200,000 participants
have enrolled in SWOG-led cancer clinical trials.
The advances in treatment and prevention that
have come from those trials have improved the lives
and health care of millions more.
Where is this trial open?
The trial will be opened at hundreds of sites all
across the country. Here's a list of SWOG institutions that have the site open. You can also find a list of additional non-SWOG sites with the trial open at the clinicaltrials.gov site (scroll down to the "Contacts and Locations" section).
Where can I learn more?
Your study doctor can answer questions and give
you an informed consent document with more information
about the RxPONDER trial. You can
learn more from the sources below.
These resources are available on the website of the
National Cancer Institute:
You may find these additional resources helpful:
This brochure is meant as a patient's introduction to the RxPONDER breast cancer clinical trial. It does not replace the
study's detailed informed consent form or information from your
study doctor. rev 7/19/11
More about SWOG
This study is designed and conducted by the Southwest Oncology Group, or SWOG, a National Cancer Institute-supported network of almost 5,000 cancer researchers at more than 500 institutions in the U.S., Canada, and beyond.
SWOG works to improve the practice of medicine in preventing, detecting, and treating cancer and to improve the quality of life for cancer survivors.
Since the 1950s more than 200,000 participants have enrolled in SWOG-led cancer clinical trials. The advances in treatment and prevention that have come from those trials have improved the lives and health care of millions more.
Learn more at swog.org.
The content on this page has been reviewed and approved for patient use by the Central Institutional Review Board (CIRB) of the National Cancer Institute (NCI).
S1007 protocol rev 20110719
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