Approximately 1 in 5 patients with breast cancer has HER2+ breast cancer.1 If you have HER2+ breast cancer, Herceptin is a therapy designed to help fight your kind of cancer.
How HER2+ breast cancer is different
Not all breast cancers are the same. HER2+ breast cancer cells have more HER2 receptors (a particular protein found on the surface of cells) than normal breast cells.
- Having too many HER2 receptors may make the cancer cells grow and divide faster, creating more HER2+ cancer cells
- HER2+ breast cancer is considered aggressive because it grows and spreads quickly
Herceptin is available for some women with HER2+ breast cancer.
Aggressive cancers are cancers that grow and spread very quickly. HER2+ breast cancer (your doctor may call it “HER2-overexpressing breast cancer”) is considered aggressive because the cells have too many HER2 receptors, which cause the cells to grow and divide too quickly.
Who is Herceptin for?
Adjuvant Breast Cancer
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)
Patients are selected for therapy based on an FDA-approved test for Herceptin
Metastatic Breast Cancer
Herceptin has 2 approved uses in metastatic breast cancer:
- Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer
- Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease
Patients are selected for therapy based on an FDA-approved test for Herceptin
Early-stage and metastatic are different stages of cancer. A cancer’s stage refers to how much the cancer has grown and where it has spread. Staging systems help describe the cancer, so that your doctor can decide what treatments will be appropriate.
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.
Indications and Important Safety Information
Gastric Cancer
Herceptin is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2-positive metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease.
Patients are selected for therapy based on an FDA-approved test for Herceptin.
Adjuvant Breast Cancer
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)
Patients are selected for therapy based on an FDA-approved test for Herceptin
Gastric Cancer
Herceptin is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2-positive metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease.
Patients are selected for therapy based on an FDA-approved test for Herceptin.
Important Patient Safety Information
Possible Serious Side Effects With 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:
These signs usually happen within 24 hours after receiving HERCEPTIN.
Be sure to contact your doctor if you:
Side Effects Seen Most Often With HERCEPTIN
Some patients receiving HERCEPTIN for breast cancer had the following side effects:
- Fever
- Feeling sick to your stomach (nausea)
- Throwing up (vomiting)
- Infusion reactions
- Diarrhea
- Infections
- Increased cough
- Headache
- Feeling tired
- Shortness of breath
- Rash
- Low white and red blood cell counts
- Muscle pain
Some patients receiving HERCEPTIN for metastatic stomach cancer had the following side effects:
- Low white blood cell counts
- Diarrhea
- Feeling tired
- Low red blood cell counts
- Swelling of the mouth lining
- Weight loss
- Upper respiratory tract infections
- Fever
- Low platelet counts
- Swelling of the mucous membranes
- Swelling of the nose and throat
- Change in taste
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 http://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.
Herceptin®, its logo and the Access Solutions logo are registered trademarks of Genentech, Inc.