Nearly two decades after a human antibody was created that treats an aggressive form of breast cancer, it is now being used in a promising new clinical research study conducted in several countries and at 80 medical sites in the United States, including Memorial Healthcare System in Hollywood.
Herceptin, created in 1990 by leading biotech company Genentech, is the first humanized antibody approved for the treatment of HER2-positive metastatic breast cancer, an aggressive disease that responds poorly to chemotherapy. Designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential, Herceptin has been shown to improve patient response rates, disease-free survival and overall survival while maintaining the quality of life in HER2-positive breast cancer patients.
Breast cancer is the most common cancer among women worldwide and the second-leading cause of cancer death among women in the United States. According to the National Cancer Institute, approximately 15 to 30 percent of breast cancers are diagnosed as HER2-positive.
Characterized by increased quantities of the HER2 protein on the surface of the tumor cells that hasten their ability to grow and spread, HER2-positive breast cancer has a greater likelihood of recurrence and a lower chance of survival than HER2-negative breast cancer.
Since it was approved for breast cancer patients in 1998, Herceptin (trastuzumab) administered in combination with chemotherapy has become a commonly used treatment for women with HER2-positive metastatic breast cancer. Despite recent advances, however, additional treatment options are needed for patients with this aggressive form of the disease.
About 27 percent of women with metastatic breast cancer – in which the disease has spread to other parts of the body such as the lungs, bones, liver and brain – survive for five years. The average survival time is only about 24 months.
The purpose of the global clinical research trial that Memorial Healthcare System is participating in is to determine the safety and effectiveness of the investigational medicine pertuzumab, a humanized antibody designed to interfere with tumor growth, when given in combination with Herceptin and chemotherapy.
The new clinical trial, known as the CLEOPATRA (CLinical Evaluation Of Pertuzumab and TRAstuzumab) study, began recruiting patients in January 2008 and is underway in 18 countries worldwide. CLEOPATRA is a Phase III double-blind, placebo-controlled trial targeting patients with previously untreated HER2-positive metastatic breast cancer.
The Phase II clinical trial of pertuzumab and Herceptin targeted metastatic breast cancer patients whose disease had progressed on Herceptin-based therapy as their most recent treatment. To be eligible for participation in that trial, patients could not have received more than three lines of previous therapy, including Herceptin and chemotherapy.
In the Phase II study, half of the participants with advanced, HER2-positive metastatic breast cancer, whose disease had progressed during treatment with Herceptin, benefited from a combination of Herceptin and pertuzumab. Nearly one in four patients saw their tumors disappear or shrink, while another 25 percent of patients saw their cancer stabilize for at least six months.
The Phase II trial results released in 2008 represent “significant promise for women with breast cancer in the future,” said Dr. Jose Baselga of the Vall d’Hebron University Hospital in Barcelona, Spain, the trial’s lead investigator. “We are hopeful the combination of Herceptin and pertuzumab used with chemotherapy will be even more effective if used to treat women newly diagnosed with advanced cancer.”
Current goals of treatment for metastatic breast cancer include symptom relief, improved quality of life and increased overall survival and disease progression-free survival. If the CLEOPATRA study proves successful, the combination of Herceptin, pertuzumab and chemotherapy has the potential to become a new standard of care in HER2-positive metastatic breast cancer.
“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 be eligible for the CLEOPATRA study, participants must be at least 18 years old and have HER2-positive metastatic breast cancer, and cannot have received treatment after the cancer has spread to other parts of the body.
For additional information on the CLEOPATRA study and its eligibility requirements, call 1-888-662-6728 or visit www.HER2study.com.
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