Continue the Fight
with Herceptin Therapy

Learn more about the benefits and risks associated with Herceptin therapy.

Metastatic Breast Cancer Treatment

If you have HER2+ metastatic breast cancer, Herceptin may help you keep fighting.

Your doctor may prescribe Herceptin, a treatment approved by the FDA for HER2+ metastatic breast cancer, as:

  • A first-line agent together with paclitaxel
  • A single agent in patients who have already received 1 or more chemotherapy regimens for metastatic disease

Herceptin with chemotherapy or alone is a treatment that you may take until your cancer spreads further or your side effects become unmanageable, so staying focused on your treatment is important.

Every person who has HER2+ breast cancer is unique, and no cancer treatment works the same for everyone. Speak to your doctor for more information about treatment with Herceptin.

Metastatic breast cancer is breast cancer that has spread to other parts of the body.
First-line metastatic therapy is treatment that is given first or as initial treatment when your cancer has spread to other parts of the body. Herceptin, taken with paclitaxel, is an approved first-line therapy for HER2+ metastatic breast cancer.

Stay focused on your treatment goals by following your Herceptin therapy as recommended by your doctor

  • Herceptin is usually given at your doctor's office or clinic.
  • Herceptin is given by an IV (intravenous) infusion, which means that it is given through a needle inserted into your vein.
  • You will most likely continue to take Herceptin until your disease grows or spreads, or until the side effects become unmanageable.

Herceptin infusion times1

First dose90 minutes
All other doses when taking Herceptin weekly30 minutes

HER2 Testing

  • You must have a HER2 test to determine if your cancer is HER2-positive before taking Herceptin, as benefit has only been shown 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
  • 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

You should contact your doctor immediately if you have any of the side effects listed above.

Please see HERCEPTIN full Prescribing Information, including Serious Side Effects, for additional Important Safety Information.

Cardiac monitoring

Why is my heart being monitored while I'm on Herceptin?

Herceptin (trastuzumab) can cause heart problems including an inability to pump blood effectively, irregular heartbeats, high blood pressure, disabling heart failure, weakening of the heart muscle, and sudden loss of heart function leading to death. Herceptin may cause reduced heart function even if there are no symptoms.

Before taking your first dose of Herceptin, your doctor should check to see if you have any health conditions that may increase your chance of having serious heart problems. This includes a review of your health history and tests to see how well your heart muscle is working. These tests may include an echocardiogram, which is an ultrasound image of the heart, or a MUGA scan, which takes a moving picture of your heart pumping blood following an injection of a radioactive substance.

In addition, you should be frequently monitored for decreasing heart function during the time you are receiving Herceptin and after your last dose of Herceptin. If you must permanently or temporarily stop Herceptin due to heart problems, you should be monitored more frequently.

Herceptin has only been approved for use in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer.

Do women on Herceptin experience heart problems?

  • 11% of patients experienced heart problems on Herceptin plus paclitaxel vs 1% paclitaxel alone.
  • 28% of patients experienced heart problems on Herceptin plus anthracycline (doxorubicin or epirubicin) (AC) and cyclophosphamide vs 7% of anthracycline (doxorubicin or epirubicin) (AC) alone.
  • 7% of patients experienced heart problems on Herceptin as a single agent.
  • In 1 pivotal clinical trial in the metastatic setting, 75% of patients with cardiac dysfunction responded to appropriate medical therapy.2
  • In the pivotal trial (N=469), of the 63 patients who had cardiac dysfunction, 44 received standard medical treatment; the condition improved with treatment in 33 of the 44 patients, did not change in 5 patients, and worsened in 4 patients.2
  • One patient each died in the Herceptin plus CT and CT-alone arms.2

Indications

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

*
High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

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

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:

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

HERCEPTIN may result in the death of an unborn baby or birth defects. Contraception 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 report HERCEPTIN exposure to Genentech at 1-888-835-2555.

Have any signs of SEVERE LUNG PROBLEMS, including

  • Severe shortness of breath
  • Fluid in or around the lungs
  • Weakening of the valve between the heart and the lungs
  • 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.

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.

References

1. Herceptin Prescribing Information. Genentech, Inc. 2017.
2. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344:783-792.