Download Herceptin HER2+ Adjuvant Breast Cancer Patient Brochure

Brought to you by
HER Breast
Cancer Handbook
Information about the testing and treatment of
HER2-positive early-stage (adjuvant) breast cancer
References:
1. American Cancer Society. Breast Cancer Facts and Figures 2015-2016 p1/Table1. http://www.cancer.org/acs/groups/
content/@research/documents/document/acspc-046381.pdf. Accessed June 2, 2016. 2. Stages of breast cancer. National
Cancer Institute. http://www.cancer.gov/cancertopics/pdq/treatment/breast/patient/page2. Accessed June 2, 2016. 3. Tumor
grade. National Cancer Institute. http://www.cancer.gov/cancertopics/factsheet/detection/tumor-grade. Accessed June 2,
2016. 4. Testing biopsy and cytology specimens for cancer. American Cancer Society. http://www.cancer.org/acs/groups/
cid/documents/webcontent/003185-pdf. Accessed June 2, 2016. 5. Pegram M, Slamon D. Biological rationale for HER2/
neu (c-erbB2) as a target for monoclonal antibody therapy. Semin Oncol. 2000;27(suppl 9):13-19. 6. Hormone receptor status.
Breastcancer.org. http://www.breastcancer.org/symptoms/diagnosis/hormone_status. Accessed June 2, 2016.
7. HercepTest™ Interpretation Manual—Breast. Dako Denmark A/S. February 19, 2010. 8. Wolff AC, Hammond MEH, Hicks
DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of
Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013;31(31):3997-4013.
9. HER2 status. Breastcancer.org. http://www.breastcancer.org/symptoms/diagnosis/her2. Updated May 16, 2016. Accessed
June 2, 2016. 10. Treatment option overview. National Cancer Institute. http://www.cancer.gov/cancertopics/pdq/treatment/
breast/patient/page5. Accessed June 2, 2016. 11. American Cancer Society. Types of cancer treatment. http://www.cancer.
org/treatment/treatmentsandsideeffects/treatmenttypes/index. Accessed June 2, 2016. 12. Herceptin Prescribing Information.
Genentech USA, Inc. 2016.
Who is HERCEPTIN for?
Herceptin is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor
Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into
the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone
receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways:
• As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either
paclitaxel or docetaxel. This treatment course is known as “AC TH”
• With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH”
• Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type
of chemotherapy)
igh risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor
H
grade 2 or 3.
*
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
©2016 Genentech USA, Inc. So. San Francisco, CA All rights reserved. Printed in USA. HER/051215/0018a(2) 04/16
What possible Serious Side Effects and Additional
Important Safety Information should I know about Herceptin?
Not all people have serious side effects, but side effects with HERCEPTIN therapy are common.
Although some people may have a life-threatening side effect, most do not.
Your doctor will stop treatment if any serious side effects occur.
HERCEPTIN is not for everyone. Be sure to contact your doctor if you are experiencing
any of the following:
HEART PROBLEMS
These include heart problems—such as congestive heart failure or reduced heart
function—with or without symptoms. The risk for and seriousness of these heart
problems were highest in people who received both HERCEPTIN and a certain type of
chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient
died of significantly weakened heart muscle. Your doctor will check for signs of heart
problems before, during, and after treatment with HERCEPTIN.
INFUSION REACTIONS, including:
• Fever and chills
• Feeling sick to your stomach (nausea)
• Throwing up (vomiting)
• Pain (in some cases at tumor sites)
• Headache
• Dizziness
• Shortness of breath
These signs usually happen within 24 hours after receiving HERCEPTIN.
2
Be sure to contact your doctor if you:
Are a woman who could become pregnant, or may be pregnant
Treatment with HERCEPTIN may result in the death of an unborn baby and
birth defects. Birth control should be used while receiving HERCEPTIN and
after your last dose of HERCEPTIN. If you are exposed to HERCEPTIN during
pregnancy or within 7 months of becoming pregnant, you are encouraged to
enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting
http://www.motherpregnancyregistry.com/ and to report HERCEPTIN exposure to
Genentech at 1-888-835-2555.
advocacy
What will
groups
I learn in this handbook?
The basics of breast cancer ................ pages 4-9
The basics of HER2 .................................. pages 10-13
Herceptin and
Possible Serious Side Effects ............. pages 14-19
Patient support ............................................ pages 20-25
The information in this brochure is not intended to replace
the advice of your doctor. If you have any questions about your
treatment, be sure to contact your healthcare team.
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
3
What is breast cancer?
Breast cancer is a tumor that begins in the breast
advocacy groups
Living Beyond Breast Cancer
www.lbbc.org or call 1-888-753-5222
Lymph Nodes
Fat
This nonprofit organization is dedicated to empowering all women
affected by breast cancer to live as long as possible with the best
quality of life.
American Cancer Society
www.cancer.org or call 1-800-227-2345
This comprehensive website offers information for patients with cancer
as well as families, friends, survivors, professionals, and volunteers.
Nipple
National Cancer Institute
www.cancer.gov or call 1-800-4-CANCER (1-800-422-6237)
Ducts
This website provides easy access to comprehensive research-based
information and resources for cancer researchers, health professionals,
patients and their families, advocates, news media, and the public.
Lobules
!
4
*The organizations here are an incomplete listing of cancer support organizations and
are not controlled by, endorsed by, or affiliated with Genentech USA, Inc. The list is
meant for informational purposes only and is not meant to replace your healthcare
professional’s medical advice. Ask your doctor or nurse any questions you may have
about your cancer or treatment plan.
An estimated 231,840 women
were diagnosed with breast cancer in
the United States in 2015.1
Please see additional select Important Safety Information throughout, and the
accompanying full Prescribing Information, including Boxed WARNINGS.
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
25
What are the potential risk factors?
While we aren’t sure of exactly what
causes breast cancer, we are aware of
certain risk factors1:
•Diet
•Smoking
• Age
• Family history
Breast cancer is discovered typically
when either a patient or physician
finds a lump in the breast. This can
happen during a self-examination or
a mammogram. However, there are
other symptoms of breast cancer
that may or may not be present1:
•Swelling of the breast
• Nipple discharge
•Breast or nipple pain
•Nipple retraction (turning inward)
•Skin irritation on the breast
Diagnosis is confirmed after a biopsy
is taken and analyzed by a pathologist.
5
5
What are the stages
of breast cancer?
What are the other characteristics
of breast cancer?
Tumor size and tumor grade can affect treatment decisions
Stage refers to how much the cancer has grown and where it has spread.
Tumor size
5 cm
4 cm
3 cm
2 cm
Stage 0 cancer does not
interfere with normal breast
tissue and is confined to
the breast.2
Stage I cancer interferes
with normal breast tissue
and may have spread to
the lymph nodes.2
Stage II cancer interferes
with normal breast tissue and
may have spread to the lymph
nodes under the arm.2
1 cm
T1
T2
T3
Tumor grade3
Stage IIIA cancer interferes
with normal breast tissue
and has spread to the lymph
nodes under the arm or near
the breastbone.2
6
Stage IIIB/C cancer has
spread to the chest wall
and/or skin of the breast,
as well as to the lymph
nodes under the arm, near
the breastbone, or near
the collarbone.2
Grade 1
Grade 2
Grade 3/4
Cells are not
growing rapidly
Cells are growing at
a moderate rate
Cells are growing and
spreading aggressively
Stage IV cancer has spread
to other organs in the body,
such as the liver or brain.2
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
7
What are the different types of
breast cancer surgeries?
Surgery is often the first type of therapy used in breast cancer1
•There are several surgical options that your doctor will choose from, based on what is best for you
What happens after surgery?
After surgery, a sample of your tumor is taken to a pathology
lab to be analyzed
Pathologist’s responsibilities4:
•The pathologist will take your sample and prepare it for testing.
There are many different steps that must be taken to ensure your
sample is accurately tested
•Once the sample is prepared for testing, the pathologist will run the
appropriate test based on the type of suspected cancer
•The pathologist will then analyze the sample and create a report
based on the findings
8
Lumpectomy
Mastectomy
Lymph Node Dissection
Only the breast tumor is removed,
as well as some surrounding
normal tissue.
The removal of the entire breast.
After the procedure, breast
reconstruction may be an option.
The lymph nodes near the breast
are removed to determine whether
the cancer has spread to the nodes.
Lymph node dissections often
accompany lumpectomies and
mastectomies.
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
9
What does the
pathologist test for?
The pathologist will test the tumor
for certain traits that may affect
treatment decisions
HER2 status5
• HER2 refers to HER2 receptors
•All cells have HER2 receptors, which are proteins
found on the surface of cells. However, in
HER2-positive breast cancer, cancer cells have
a higher-than-normal number of HER2 receptors
•Having too many HER2 receptors may make the cancer
grow and divide faster, creating more HER2-positive
cancer cells
Hormone-receptor status6
•The presence of hormone receptors in your breast
cancer cells means that these cells grow when
hormones from your body attach to these receptors
•The 2 types of hormone receptors you may hear
about are estrogen receptors (ER) and progesterone
receptors (PR)
•If you have estrogen or progesterone receptors, your
breast cancer is estrogen receptor-positive (ER+) or
progesterone receptor positive (PR+) and you have
hormone receptor-positive (HR+) breast cancer
10
How is HER2 testing conducted?
The most common methods for testing HER2
IHC
FISH
Breast cancer cells are examined under a
microscope to see whether there is too much
HER2 protein present on the cell surface.
The cell nucleus controls cell growth and
reproduction. FISH testing measures the number
of copies of the HER2 gene in the nucleus.
(immunohistochemistry)
(fluorescence in
situ hybridization)
•The pathologist will interpret the results and score the patient as HER2-positive, HER2-negative,
or equivocal (which means that the tumor is considered neither HER2-positive nor HER2-negative)
•IHC test results are scored as negative (0 or 1+), equivocal (2+), or positive (3+)7
•FISH test results are scored as negative, equivocal, or positive8
!
If you have questions about
HER2 testing or your HER2 results,
please contact your healthcare team.
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
11
Why is HER2 testing important?
HER2 testing
•You must have a HER2 test to determine if your cancer is HER2-positive before taking Herceptin,
as treatment benefit has only been shown in patients whose tumors are HER2-positive
How might HER2 status
impact your treatment?
The results of your HER2 test, based on the pathology review, are given to
your oncologist to help determine the appropriate course of treatment
Approximately 1 in 5 patients is HER2-positive, so it is important
to find out your HER2 status5,9
Pathology Results
HER2 Testing Method:
Percent Staining:
Normal cell
HER2-positive cancer cell
IHC Score:
HER2 Status:
Pathologist
In a normal breast cancer cell,
HER2 receptors send signals telling
cells to grow and divide.
HER2-positive breast cancer cells have too
many HER2 receptors, which may make
cancer cells grow and divide faster.
HER2-positive breast cancer is considered aggressive
because it grows and spreads more quickly5
12
Pathology Report
!
Oncologist
Patient
Accurate HER2 testing is extremely important.
If you are HER2-positive, you can potentially
benefit from a therapy that targets HER2.
To learn more about pathology reports, visit www.breastcancer.org/symptoms/diagnosis
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
13
What are the different therapies
used to treat breast cancer?
What is Herceptin?
There are a number of therapies used in the treatment of breast
cancer. Your doctor will determine which therapy is best for you10,11
Herceptin is a targeted therapy designed to combat tumor
cell growth in HER2-positive breast cancer12
Surgery is the removal of cancer from the breast.
How Herceptin may work
In preclinical studies,
Herceptin was shown to
attach to HER2 receptors
Radiation therapy uses high-energy rays to kill
tumor cells and/or shrink tumors.
Inside the cell
Chemotherapy is a type of medicine that kills cells
•Herceptin may stop the HER2
that grow and divide rapidly; these can include cancer cells
or normal cells.
receptors from telling the cell
to grow
Hormonal therapy helps fight against tumors that
Outside the cell
thrive on hormones like estrogen and progesterone by
blocking hormone receptors.
•In preclinical studies, it was shown
that once bound to the HER2
receptor, Herceptin may be able
to flag tumor cells for destruction
by the immune system
Targeted therapy is different from other types of
therapy. Targeted therapy is a type of medicine that is
designed to attack specific cancer cells, but may also affect
healthy cells.
Possible Serious Side Effects: Heart Problems
14
These include heart problems—such as congestive heart failure or
reduced heart function—with or without symptoms. The risk for and
seriousness of these heart problems were highest in people who received
both HERCEPTIN and a certain type of chemotherapy (anthracycline). In
a study of adjuvant (early) breast cancer, one patient died of significantly
weakened heart muscle. Your doctor will check for signs of heart
problems before, during, and after treatment with HERCEPTIN.
• Normal cells also have HER2 (just not as much), so HER2-targeted therapies can also affect healthy cells
and can cause side effects, including serious side effects
Herceptin can be taken with certain chemotherapies
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
15
Why is heart monitoring necessary while receiving Herceptin therapy?
Your healthcare team will monitor your heart to stay on top of potential
cardiac issues and catch them early on so they can be properly treated12
Your heart will be monitored at baseline, every 3 months while on a 1-year course of Herceptin
therapy, and upon completion. Heart function will be tested with an ECHO* or MUGA† scan12
DURING HERCEPTIN THERAPY12
AFTER HERCEPTIN THERAPY12
HOLDING HERCEPTIN
In case of reduced heart function without symptoms, your doctor may hold Herceptin therapy up to 3 times.
your heart should be monitored
every 6 months for at least 2 years
RESTARTING HERCEPTIN
Your doctor may restart Herceptin therapy up to 3 times if your heart function improves and returns to
normal limits after Herceptin has been held.
DISCONTINUING HERCEPTIN
Herceptin will be discontinued if you experience CHF or significantly reduced heart function (when the heart
can’t keep up with the amount of blood flowing through it).
Possible Serious Side Effects: INFUSION REACTIONS, including:
• Fever and chills
• Headache
• Feeling sick to your stomach (nausea) • Dizziness
• Throwing up (vomiting)
• Shortness of breath
Pain
(in
some
cases
at
tumor
sites)
•
These signs usually happen within 24 hours after receiving HERCEPTIN.
*ECHO scan is an ultrasound image of the heart.
MUGA scan takes a moving picture of your heart pumping blood
following an injection of a nontoxic radioactive substance.
†
16
Please see additional select Important Safety Information throughout, and the
accompanying full Prescribing Information, including Boxed WARNINGS.
17
What possible Serious Side Effects and Additional Important Safety Information
should I know about Herceptin?
Not all people have serious side effects, but side effects with HERCEPTIN therapy are common.
Although some people may have a life-threatening side effect, most do not.
Your doctor will stop treatment if any serious side effects occur.
HERCEPTIN is not for everyone. Be sure to contact your doctor if you are experiencing any of
the following:
HEART PROBLEMS
These include heart problems—such as congestive heart failure or reduced heart function—with or
without symptoms. The risk for and seriousness of these heart problems were highest in people who
received both HERCEPTIN and a certain type of chemotherapy (anthracycline). In a study of adjuvant
(early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for
signs of heart problems before, during, and after treatment with HERCEPTIN.
INFUSION REACTIONS, including:
• Fever and chills
• Feeling sick to your stomach (nausea)
• Throwing up (vomiting)
• Pain (in some cases at tumor sites)
•Headache
•Dizziness
• Shortness of breath
These signs usually happen within 24 hours after receiving HERCEPTIN.
Be sure to contact your doctor if you:
Are a woman who could become pregnant, or may be pregnant
Treatment with HERCEPTIN may result in the death of an unborn baby and birth defects. Birth control
should be used while receiving HERCEPTIN and after your last dose of HERCEPTIN. If you are
exposed to HERCEPTIN during pregnancy or within 7 months of becoming pregnant, you are
encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting
http://www.motherpregnancyregistry.com/ and to report HERCEPTIN exposure to Genentech
at 1-888-835-2555.
18
Have any signs of SEVERE LUNG
• Severe shortness of breath
• Fluid in or around the lungs
• Weakening of the valve between the heart and the lungs
PROBLEMS, including
• Not enough oxygen in the body
• Swelling of the lungs
• Scarring of the lungs
Your doctor may check for signs of severe lung problems when he or she examines you.
Have LOW WHITE BLOOD CELL COUNTS
Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in
patients receiving HERCEPTIN plus chemotherapy than in patients receiving chemotherapy alone.
Your doctor may check for signs of low white blood cell counts when he or she examines you.
Other Important Information
Before taking HERCEPTIN, you must have a HER2 test to determine if your cancer is HER2-positive. This
is because the benefit of treatment with HERCEPTIN has been shown only in patients whose tumors are
HER2-positive.
Side Effects Seen Most Often With HERCEPTIN
Some patients receiving HERCEPTIN for breast cancer had the following side effects:
•Fever
•Headache
Feeling
sick
to
your
stomach
(nausea)
•
•Feeling tired
•Throwing up (vomiting)
•Shortness of breath
•Infusion reactions
•Rash
•Diarrhea
•Low white and red blood cell counts
Infections
•
•Muscle pain
•Increased cough
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA.
You may report side effects to the FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to
Genentech at 1-888-835-2555.
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
19
What are the benefits of the HERConnection program?
Supporting you through your journey with
early-stage HER2-positive breast cancer
Join this free educational program
to get information and helpful
advice from registered oncology
nurses to help you stay on track
with your treatment.
Get information
and resources about
HER2-positive
breast cancer
HERConnection
Patient Support Line
Talk to registered oncology nurses who can answer
questions about:
We tailor HERConnection to your needs by:
•How Herceptin is designed to work
•The potential benefits and risks of Herceptin
•Side effects of Herceptin
•What to expect from Herceptin treatment
•Finding reimbursement help for Herceptin
specific points during your treatment
•Sending you a series of emails and postal
mailings about HER2-positive breast cancer
and Herceptin treatment
•Providing information and resources at
The information you receive from the HERConnection Patient Support Line is not meant to replace
the advice of your healthcare team. Genentech will not provide medical advice regarding your
medical condition or treatment.
Call 866-449-HER2 or join online at www.HERConnection.com
20
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
21
Financial support and resources
Herceptin Access Solutions®
Herceptin Access Solutions may be able to help you get the medicine you need.
How does Access Solutions work?
Getting Started With Genentech Access Solutions
When seeking help from Herceptin Access Solutions, there are 2 forms you and your doctor need to complete:
To learn more about how we can help,
contact us. Call (888) 249-4918 or visit
Genentech-Access.com/Herceptin
The Statement of Medical Necessity, or SMN—a form filled out by your doctor
Genentech BioOncology Co-pay Card
The Patient Authorization and Notice of Release of Information, or PAN—a form you must sign and date.
This form lets us discuss your case with your doctor and your health care plan.
Genentech offers the Genentech BioOncology Co-pay Card to help eligible patients with the
out-of-pocket (OOP) costs associated with Herceptin.
Genentech Access to Care Foundation
®
The Genentech® Access to Care Foundation (GATCF) helps people who have health insurance
and those who don’t. If you qualify for GATCF, you could receive Herceptin free of charge.
To get started, the first thing you need to do is complete the PAN form. Be sure to fill in all required information. Herceptin
Access Solutions must have a completed PAN before we can begin working with you or your doctor’s office. For Herceptin
Access Solutions to work with you, you must complete and submit the PAN form. Your doctor must also complete a form
called the SMN form. Once we have both the SMN and PAN forms, we can begin working with you and your doctor’s office.
Your PAN form is valid for only 1 year. You must complete and submit one to Herceptin Access Solutions every year.
You can complete the PAN in 1 of 2 ways:
Fill out and submit the paperless PAN form online
Sign a printed form and fax or mail it to us (or give it to your doctor’s office to do so)
Where to find the PAN form
You can find the PAN form at Genentech-Access.com/Herceptin or your doctor might give it to you.
You can download the PAN form or fill it out online at Genentech-Access.com/Herceptin.
22
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing Information,
including Boxed WARNINGS.
23
Educational resources and
There are support groups and national
organizations that may be helpful to you
and your family *
Breastcancer.org
www.breastcancer.org
This website is dedicated to providing reliable and current
medical information about treatment options, symptoms,
diagnosis, and prevention. The site also includes up-to-date
research news, online “ask the expert” conferences, and
discussion boards.
HER2 Support Group
www.her2support.org
This site offers information on news and current research
for HER2-positive breast cancer, along with online
message boards, which serve as forums for discussion
among patients, family members, caregivers,
and medical professionals.
24