Memorial Healthcare System Participating in Global Clinical Study to
Evaluate Potential Targeted Treatment for Aggressive Form of
Breast Cancer

Despite Recent Advances, Women with HER2-Positive Metastatic Breast Cancer Need Additional Options

Tuesday, September 22 2009

FOR IMMEDIATE RELEASE:

(Hollywood, Fla.) – Breast cancer is the second-leading cause of cancer death among women in the United States.1 Although medicines such as Herceptin® have changed the course of HER2-positive breast cancer, it remains an aggressive form of the disease, and new medicines are needed for women with advanced disease.

The Memorial Healthcare System is participating in the CLEOPATRA study, a Phase III global clinical research study, to determine if the investigational medicine, pertuzumab — when given with a commonly used targeted cancer treatment, Herceptin, and chemotherapy — is safe and effective, compared to an inactive placebo, Herceptin, and chemotherapy.

To be eligible for the CLEOPATRA study, participants must be at least 18 years old, have HER2-positive metastatic breast cancer, and cannot have received treatment after the cancer has spread to other parts of the body. The Memorial Healthcare System is one of 80 institutions across the country seeking study participants.

“Research into new treatments is vital to continue the progress being made against this deadly disease,” said Dr. Alejandra Perez, Director of Breast Cancer for the Memorial Healthcare System. “The CLEOPATRA study will tell us more about pertuzumab’s potential role in treating women in the future with HER2-positive metastatic breast cancer.”

To determine if you may be eligible to participate in the CLEOPATRA study, please visit www.HER2study.com or call 1-888-662-6728.

About HER2-Positive Metastatic Breast Cancer
Breast cancer is the uncontrolled growth of cancerous cells that start in breast tissue. Breast cancer can be either HER2-postive or HER2-negative, based on genetic characteristics of the cancer. These two types may have different outcomes.

Women with HER2-positive breast cancer have tumors that tend to grow and spread more quickly than tumors that are not HER2-positive and have a greater likelihood of recurrence.2

Approximately 15 to 30 percent of breast cancers are HER2-positive.3 In HER2-positive metastatic breast cancer, the disease has spread to other parts of the body, most commonly to the lungs, bones, liver and brain.4

At this stage of the disease, finding a cure is an unlikely outcome for women with metastatic breast cancer. The current goals of treatment include symptom relief, improved quality of life, increasing the amount of time women with metastatic breast cancer live (overall survival), and increasing the amount of time women with metastatic breast cancer live without the cancer worsening (progression free survival).

About the Study Medicines
Pertuzumab is an investigational, targeted medicine designed to interfere with tumor growth. The study medicine may inhibit the ability of the HER2 protein to interact with other proteins that, when paired with HER2, may cause cancer cells to multiply and spread more rapidly.

In September 1998, Herceptin was approved in combination with chemotherapy (paclitaxel) for treatment of women who had not received previous medicines for their advanced (metastatic)
HER2-positive breast cancer (first-line treatment). It was also approved as a medicine to be used alone for women who had received prior chemotherapy (second- and third-line treatment).5

In November 2006, Herceptin was approved for treating early-stage (adjuvant) HER2-positive breast cancer when given with chemotherapy (doxorubicin, cyclophosphamide and paclitaxel), a combination called AC-TH. In January 2008, it was also approved as a stand-alone medicine following anthracycline-based chemotherapy.5 In May 2008, Herceptin and chemotherapy (docetaxel and carboplatin), known as TCH, was approved. This treatment regimen has been associated with a lower risk of heart damage when compared to other combinations of Herceptin and chemotherapy.5 Another AC-TH combination, comprised of Herceptin, doxorubicin, cyclophosphamide and docetaxel, was also approved in May 2008.5

Herceptin treatment can result in heart problems, including those without symptoms (reduced heart function) and those with symptoms (congestive heart failure). Some patients have had serious infusion reactions and lung problems; fatal infusion reactions have been reported. Worsening of low white blood cell counts associated with chemotherapy has also occurred. The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and
muscle pain.

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, talk to your doctor.

Please visit www.gene.com for the Herceptin® (trastuzumab) full prescribing information, including Boxed WARNINGS and additional important safety information.

The combination of Herceptin and chemotherapy is a commonly used treatment for women with
HER2-positive metastatic breast cancer.6

The sponsor of the CLEOPATRA study is Genentech Inc., a wholly-owned member of the Roche Group.

The study medication is investigational only and has not been approved for use outside a clinical setting.

References
1 American Cancer Society. “Cancer Facts and Figures 2009.” http://www.cancer.org.
Accessed May 7, 2009.
2 Genentech Inc. “What is HER2?” http://www.herceptin.com/her2-breast-cancer/testing-education/what-is.jsp
Accessed July 20, 2009.
3 American Cancer Society. “Breast Cancer Facts and Figures 2007-2008.” http://www.cancer.org. Accessed May 7, 2009.
4 National Cancer Institute. “Metastatic Cancer: Questions and Answers.” http://www.cancer.gov/cancertopics/factsheet/Sites-Types/metastatic
Accessed April 28, 2009.
5 Herceptin [package insert]. South San Francisco, Calif.: Genentech, Inc. 2009.
6 NCCN Clinical Practice Guidelines in Oncology: Breast Cancer, v.1.2009.

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