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For patients with metastatic breast cancer (MBC), the course of the disease can be highly unpredictable. That’s why accurate information regarding your disease state at any given time during therapy is an essential part of your care.

The detection of CTCs in the blood can provide doctors with valuable insight into the progression of MBC. Clinical studies have shown that detection of CTCs can predict disease progression and survival in those with MBC.

By measuring the number of CTCs in the blood before and during the course of treatment, doctors can predict progression-free survival (PFS) and overall survival (OS) more accurately. With this information, doctors can better monitor their patient’s progress and make more-informed patient care decisions.

CellSearch^® CTC Test

The CellSearch^® CTC Test from Veridex is a powerful tool that can help doctors predict disease progression and survival in patients with MBC.

It is a simple blood test that captures, identifies, and counts CTCs in a tube of blood. Clinical studies have shown that:

• 5 or more CTCs in a blood sample are an indication that the disease is progressing
• fewer than 5 CTCs in the sample indicates that the disease is not currently progressing and that the patient has a better prognosis

In cases where the test indicates the presence of 5 or more CTCs, the doctor may use this and other clinical factors to determine if a change to the patient’s care is needed.

The CellSearch^® CTC Test offers patients and their doctors other benefits as well, including:

• Convenience
  The test is performed with a blood sample from the patient, which can be taken right in the doctor’s office, in a hospital, or in a clinic.
• Accuracy
  CTCs are a strong, independent predictor of both progression-free survival (PFS) and overall survival (OS), a fact that has been proven by results from more than 4 years of clinical study. Studies have also found that the CTC test provides information about a patient’s prognosis that is similar to imaging¨Donly sooner.
• Flexibility
  Not only can the CellSearch^® CTC test be performed earlier than traditional imaging, it can also be performed at any time during the course of treatment. This can help doctors make important decisions about patient care earlier, and as needed.

To learn if the CellSearch^® CTC Test is right for you, talk to your doctor. If your doctor is not familiar with the test, he or she can learn more by going to www.veridex.com, or by calling 1-877-VERIDEX and selecting option 6.

How the CTC test is different

Unlike traditional diagnostic tests such as imaging¨Dwhich focuses on changes in tumor size¨Dthe CellSearch^® CTC test:

• measures the number of CTCs in the blood to help predict the patient’s prognosis
• is a simple blood test that can be taken right in the doctor’s office
• can be performed at the start of therapy, and at any time during the course of treatment

This critical information can help the doctor make important patient care decisions earlier, and as needed. Ask your doctor if the CellSearch^® CTC Test is right for you.

Why you need to be monitored

Once you are diagnosed with Metastatic Breast Cancer (MBC) and have begun therapy, it is important for the doctor to regularly assess your prognosis. By monitoring you throughout your treatment, your doctor can make more-informed decisions about your care.

Traditional methods of monitoring include:

• physical exams
• laboratory tests
• serum tumor markers

Another common method involves radiographic imaging, such as the CT scan. Imaging is performed at certain intervals of time¨D typically starting about 12 weeks after a particular therapy has begun¨Dand is used to measure changes in the size of the tumor to determine if therapy is having an effect.

Another, newer method for monitoring MBC is the CellSearch^® CTC Test. Unlike imaging, the CTC test counts the number of cancer cells that have broken away from the tumor and are currently circulating in the blood stream. Clinical studies have shown that detection of these cells can predict disease progression and survival in patients with MBC.

A CTC test can be performed at the start of therapy, and then as early as the end of the first cycle of therapy. There’s no need to wait 12 weeks, as is the case with imaging. This flexibility allows doctors to make informed patient care decisions earlier.

References:
1. Facts for Life: Metastatic Breast Cancer. Susan G. Komen for the Cure. Available at: http://cms.komen.org/stellent/groups/public/documents/komen_document/011056.pdf. Accessed June 2007.
2. Metastatic Breast Cancer. All about Life Challenges. Available at: http://www.allaboutlifechallenges.org/Metastatic-Breast-Cancer.htm. Accessed June 2007.
3. Patient Resource Cancer Guide: Metastatic Breast: http://www.patientresource.net/userfiles/files/Metastatic%20Breast_LO.pdf.

This publication includes content for patients facing advanced & metastatic breast cancer. It discusses diagnostic testing, treatment strategies, symptom management and the emotional & psychological effects of living with this disease. A list of financial and advocacy support groups is also included.

Q: What is the CellSearch^® CTC Test?

A: The CellSearch^® CTC Test is a simple blood test that captures, identifies, and counts circulating tumor cells (CTCs) in a tube of blood. Clinical studies have shown that detection of these cells can predict disease progression and survival in women with metastatic breast cancer.

Q: What are circulating tumor cells (CTCs)?

A: CTCs are cancer cells that have detached from a solid tumor and entered into the bloodstream. These cells play an important role in the metastatic process, and their presence can provide valuable insight into disease progression.

Q: How does this information help my doctor?

A: Measuring the number of CTCs in your blood before and during your course of treatment can help your doctor in monitoring your progress. Clinical studies have shown that 5 or more CTCs in a blood sample are an indication that the disease is progressing. If your test shows there are less than 5 CTCs in your sample, that means the disease is not currently progressing. If it shows an increase to 5 or more, your doctor may choose to adjust your treatment accordingly.

Q: What types of tests do doctors currently use?

A: Currently, doctors use lab tests, physical exams, and radiographic imaging studies, such as CT scans, to determine progression of the disease. Imaging measures changes (both increases and decreases) in the size of the tumor to determine if the treatment is working. Depending on the type of treatment, imaging is performed at different intervals of time, but it typically starts about 12 weeks after therapy has begun.

Q: How is the CTC test different?

A: Unlike traditional diagnostic tests, such as imaging, the CTC test measures the number of CTCs in your blood to help determine whether or not the disease is progressing. The test can be performed at the start of therapy and at any time during the course of your treatment. This critical information can help your doctor make important treatment decisions earlier, and as needed.

Q: If I have metastatic breast cancer, should I ask for the test?

A: Every patient is different, so you should discuss the test with your doctor to determine whether it is right for you.

Q: How often should I get the CTC test?

A: Typically, a blood sample is taken for the CTC test before a new line of therapy begins to establish a baseline, and then again at any time during the course of your treatment. You should discuss with your doctor the frequency of testing that is right for you.

Q: Where do I get the CellSearch^® CTC Test?

A: Since it is a simple blood test, any doctor can order the CTC test. The blood sample can be drawn right in the doctor’s office.

Q: What if my doctor doesn’t know about the CellSearch^® CTC Test?

A: Your doctor can learn more about the test by going to www.veridex.com, or by calling 1-877-VERIDEX and selecting option 6.

Q: Who is Veridex?

A: Veridex, the company that brings you the CellSearch^® CTC Test, is a Johnson & Johnson company dedicated to delivering innovative new cancer diagnostic tools that positively impact patients’ lives.


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