About Breast Cancer
GEMZAR is approved by the FDA in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.
GEMZAR can suppress bone marrow function, which may cause low blood cell counts.
Invasive Breast Cancer
Noninvasive Breast Cancer
Subtypes of Breast Cancer
Risk Factors for Breast Cancer
Signs and Symptoms of Early-Stage Breast Cancer
Signs and Symptoms of Metastatic Breast Cancer
Invasive Breast Cancer
There are two kinds of breast cancer, "invasive" and "noninvasive." Invasive breast cancer is the more serious of the two types. It happens when abnormal cells from inside the breast's lobules or ducts spread into the surrounding breast tissue. This allows the cancer to spread to the lymph nodes and, in advanced stages, to areas such as the liver, lungs, and bones.
Healthcare professionals now believe that cancer cells can spread from the breast through the blood and lymphatic system at early stages of the disease, even though these spreading cancer cells do not always survive.
A phrase that you may hear from your healthcare team is the term "locally advanced" breast cancer. This is usually referred to as cancer that has not spread to another area in the body. However, the following issues may nonetheless have occurred1:
- The cancer in the breast may be bigger than 5 centimeters across
- The cancer may have spread into the skin or muscle of the chest, or
- There may be cancer in the lymph nodes under the arm
Locally advanced breast cancer can be any or all of the above. Locally advanced could mean either stage II or stage III breast cancer (see Diagnosis and Staging).
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Noninvasive Breast Cancer
"In situ" means "in place" and the term "carcinoma in situ" is used to describe this condition because the cancer cells remain in their original location and do not spread, or "metastasize" to the surrounding tissue or beyond. When abnormal cells grow inside the lobules, it is called "lobular carcinoma in situ." When abnormal cells grow inside the milk ducts, it is called "ductal carcinoma in situ."1 Please note that GEMZAR is not indicated for noninvasive breast cancer.
Carcinoma in situ is thought of as a precancerous condition because it can develop into or raise your risk for a more serious, invasive cancer.1
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Subtypes of Breast Cancer
Many types of breast cancer are diagnosed, and some of them are very rare. In some instances a breast tumor can be a combination of these types, and even contain a mixture of invasive and noninvasive types.2 GEMZAR in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.
- Ductal carcinoma in situ (also called "DCIS")
The most common type of noninvasive breast cancer, DCIS is found only in the ducts, and has not spread. Nearly all women with cancer at this stage can be cured. Early diagnosis is possible with a mammogram.2
- Lobular carcinoma in situ (also called "LCIS")
Begins in the milk-making glands but has not spread through the wall of the lobules. Although not a true cancer, having LCIS increases a woman's risk of getting cancer later. Women with LCIS should definitely screen for cancer.2
- Invasive (infiltrating) ductal carcinoma (also called "IDC")
The most common form of breast cancer, IDC starts in a milk passage or duct, breaks through the wall of the duct, and invades the breast tissue. From there it can spread to other parts of the body. IDC accounts for about 8 out of 10 invasive breast cancers.2
- Invasive (infiltrating) lobular carcinoma (also called "ILC")
Starts in the milk glands or lobules, where it can spread to other parts of the body. ILC accounts for roughly 1 out of 10 invasive breast cancers.2
- Inflammatory breast cancer (also called "IBC")
A rare type of invasive breast cancer that accounts for about 1% to 3% of all breast cancers. Usually there is no lump or tumor. Instead, IBC makes the skin of the breast look red and feel warm, and gives the skin a thick, pitted appearance that is not caused by inflammation or infection, but by cancer cells blocking lymph vessels in the skin. IBC is often mistaken for an infection in its early stages, and may not appear on a mammogram.2
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A risk factor is something that can affect a person's chance of getting a disease such as breast cancer.2
Risk Factors for Breast Cancer
The exact cause of breast cancer remains unknown, although several risk factors have been linked to the disease. Some risk factors can be controlled. Others, like a person's age, can't be changed. Having one or more risk factors does not mean that a person will get the disease.3
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Signs and Symptoms of Early-Stage Breast Cancer4
The most common sign of breast cancer is a new lump or mass. A lump that is painless, hard, and has uneven edges is more likely to be cancer. However, some cancers are tender, soft, and rounded, so it's important to have anything unusual checked by your healthcare team.
Other signs of breast cancer include the following:
- Thickening of the nipple or breast skin, redness, or scaliness
- Swelling of all or a portion of the breast
- The nipple turning inward or pain in the nipple
- Pain in the breast
- A discharge from the nipple, other than breast milk
- A lump in the underarm area
- Dimpling or irritation of the skin
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Signs and Symptoms of Metastatic Breast Cancer5
Metastatic breast cancer occurs when breast cancer cells spread to other parts of the body and form new cancers. The most common areas of the body where breast cancer spreads include the lungs, bones, liver, brain, and lymph nodes outside of the underarm area.
If you have had breast cancer and experience any of the following signs and symptoms that may indicate the original cancer has spread, see your doctor right away.
Symptoms of cancer in or around the lungs may include:
- Shortness of breath
- A cough that does not go away and progressively worsens (a dry cough or one that produces mucus or blood)
- Chest pain that cannot be explained
- Loss of appetite and potentially weight loss
Symptoms of cancer in the bones may include:
- Pain in the back, bone, or joints that lasts for two to three weeks and worsens over time
- Weakness or numbness in an area of the body
Symptoms of cancer in the liver may include:
- Ongoing belly pain that gets worse with time and has no known cause
- Bloating and fullness of the belly
- Jaundice (a yellowing of the skin and eyes)
- Loss of appetite and potentially weight loss
Symptoms of cancer in the brain may include:
- Blurry, double, or loss of vision
- Change in personality
- Loss of balance
- Arm or leg weakness
- Headaches
- Nausea
- Confusion
- Seizure
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Now let's take a look at the diagnosis and staging of breast cancer.
Indications and Important Safety Information for GEMZAR
GEMZAR is approved by the FDA in combination with carboplatin (another type of chemotherapy) for the patient with advanced ovarian cancer that has returned at least 6 months after the patient had finished platinum-based therapy.
GEMZAR is approved by the FDA in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients (for whom surgery is not possible) with locally advanced (stage IIIA or stage IIIB) or metastatic (stage IV or cancer that has spread) non-small cell lung cancer.
GEMZAR is approved by the FDA in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.
GEMZAR is approved by the FDA as a single agent (given alone) as the first-line treatment for patients with locally advanced (stage II or stage III when surgery is not an option) or metastatic (stage IV) adenocarcinoma of the pancreas. GEMZAR is also indicated for patients previously treated with 5-FU (another type of chemotherapy).
GEMZAR can suppress bone marrow function, which may cause low blood cell counts.
GEMZAR may not be appropriate for some patients.
If you are allergic to GEMZAR, tell your doctor because you should not receive it.
GEMZAR given for longer than 60 minutes or more than once a week has caused increased side effects.
You should call your doctor right away if you have any symptoms of infection, such as a fever or chills. If you notice bleeding, unexplained bruising, or symptoms of anemia, contact your healthcare team, as these can be symptoms of low blood cell counts.
Serious lung problems, sometimes fatal, have been reported with GEMZAR. Tell your healthcare team if you develop breathing problems.
There have been reports of serious kidney or liver damage including failure with GEMZAR treatment, sometimes fatal. If you have had kidney or liver problems or impairment, please tell your healthcare team. GEMZAR may not be right for you.
You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood tests and on your general condition.
If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team.
Patients who receive radiation therapy before, during, or after receiving GEMZAR may sometimes experience more side effects, especially at the site of the radiation.
Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, or herbal supplements.
There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea; vomiting; constipation; diarrhea; rash; shortness of breath; muscle aches; blood in urine; hearing changes and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. Lab work may identify additional side effects. If you have any side effect that bothers you or that does not go away, be sure to talk with your doctor. Call your healthcare team right away if you have fever or chills. These symptoms could mean you have an infection.
If you are pregnant, GEMZAR may cause fetal harm to your unborn baby. It is not known if GEMZAR passes into breast milk; because of the potential for serious side effects in nursing infants, discuss breast feeding and GEMZAR with your doctor. The safety and effectiveness of GEMZAR in children has not been established.
For more information about all of the side effects of GEMZAR, please talk with your healthcare team, see the full Prescribing Information, or call 1-800-545-5979.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088.
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