Download patient brochure for this clinical trial. - St. Peter's Hospital

Stephen H. Wrzesinski, M.D., Ph.D.
ST. PETER’S CANCER CARE CENTER
317 South Manning Boulevard
Albany, NY 12208
518-525-6739
www.sphcs.org
CLINICAL STUDY
Breast Cancer: NSABP B47
A Phase III Trial of Adjuvant Therapy Comparing
Chemotherapy Alone to Chemotherapy plus
Trastuzumab in Women with Node-Positive or High-Risk
Node-Negative HER2-Low-Invasive Breast Cancer
MEDICAL ONCOLOGIST/ HEMATOLOGIST,
St. Peter’s Cancer Care Center
PRINCIPLE INVESTIGATOR,
Clinical Study
Where Can I Get More
Information?
• Call the Research Department at
St. Peter’s Cancer Care Center at
(518) 525-6739
• Visit St. Peter’s website at
www.sphcs.org
• Call the NCI’s Cancer Center
Information service at;
1-800-4-CANCER
(1-800-422-6237)
• Visit NCI’s website at
www.cancer.gov
Dr. Stephen Wrzesinski received his medical degree
and doctor of philosophy degree in microbiology and
immunology from the State University of New York Upstate
Medical University in Syracuse. Board-certified in both
Medical Oncology and Internal Medicine, he completed
his residency in internal medicine at Dartmouth-Hitchcock
Medical Center in Lebanon, New Hampshire. He
completed a medical oncology fellowship at Yale Cancer
Center and Yale University School of Medicine.
Dr. Wrzesinski has been involved in cancer research
studies for more than a decade. He has also published
cancer immunotherapy reviews in top tier journals. He is
an associate member of the American Society of Clinical
Oncology and the American Association for Cancer
Research and is an active member of the Society for
Immunotherapy of Cancer (SITC).
Advanced treatment options, dedicated professionals
and a unique caring environment make St. Peter’s
one of the most well-regarded health systems.
In recent years, St. Peter’s Hospital has been recognized
by national and state health care quality organizations
for excellence in care. We offer a comprehensive,
integrated continuum of services – ranging from
acute care in the hospital to outpatient services,
home care, nursing homes, hospice care,
addictions treatment and much more.
St. Peter’s continues to set the pace
for health care innovations. We are 4,500 professionals
who know that technology is critical to treatment,
but compassion is the key to healing.

Who Can Participate In This Study?
What Is Involved In This Study?
This study is a clinical trial for female patients
diagnosed with early stage breast cancer that has
been removed by surgery. You can participate in
this study if:
• You have Node-Positive or High-Risk Node-
Negative HER2-Low Invasive Breast Cancer;
and,
• Your physician has told you that chemotherapy
and other therapy after surgery will lower the
chance of your cancer returning; and,
• Your blood tests and other tests show that you
are eligible for the study.
If you decide to participate in this study, you will
read and sign a consent form that explains the study
in more detail. If you meet all of the study requirements,
you will then be entered into the study.
If you have been diagnosed
with breast cancer,
you may be able to
participate in a new clinical
study entitled:
NSABP B47: A Phase III Trial of Adjuvant
Therapy Comparing Chemotherapy
Alone (Six Cycles of Docetaxel plus
Cyclophosphamide or Four Cycles of
Doxorubicin plus Cyclophosphamide
Followed by Four Cycles of Weekly
Paclitaxel) to Chemotherapy plus
Trastuzumab in Women with Node-
Positive or High-Risk Node-Negative
HER2-Low-Invasive Breast Cancer
What Is A Clinical Study?
Clinical studies (or “trials”) are a type of
research involving patient volunteers. They are
designed to find better ways to treat disease.
Why Is This Study Being Done?
The purpose of this study is to determine if adding
a targeted therapy, trastuzumab (Herceptin ® ),
to standard treatment with chemotherapy for
early stage, HER2-low breast cancer, will prevent
breast cancer from returning.
This study will also determine if adding
trastuzumab to treatment with chemotherapy
will help women with HER2-low breast cancer
live longer.
Who Is Conducting This Study?
This study is being conducted by the National
Surgical Adjuvant Breast and Bowel Project
(NSABP), a research group funded by the National
Cancer Institute (NCI).
Will My Insurance Cover The Costs?
You may want to speak with your health care
provider and insurance company about the costs
of any medications, radiation and/or surgery that
would be necessary.
What Will I Have To Do During
The Study?
If you choose to participate in this study, you will
have some tests done. The tests include, but are
not limited to:
• Health history and physical exam
• Laboratory studies and blood tests
• Mammogram or MRI of your breasts
• Echocardiogram or MUGA scan
• ECG (electrocardiogram)
What Are The Benefits of Being In
This Study?
This study will help doctors learn more about
the use of trastuzumab with chemotherapy as
a treatment for HER2-low breast cancer. This
information could improve your health and
help future breast cancer patients.
Are There Possible Side Effects?
You may experience side effects while in this
study. Your doctor or nurse will explain them
to you.
Am I Required To Be In This Study?
No. Taking part in this study is voluntary.
You are free to choose to participate, not to
participate, or to leave the study at any time.
If you decide not to take part in this study, your
doctor will discuss other treatment options
with you.
How Do I Participate?
If you are interested in this study, please
speak to your doctor and the members of
your health care team to discuss the possible
benefits and risks of participating. You should
feel free to discuss this brochure and this study
with your family and friends.