What Have Clinical Trials with Herceptin Shown?
Herceptin was shown to slow the growth and spread of cancerous tumors in a number of clinical trials prior to FDA approval in 1998. In some cases, cancerous tumors completely disappeared in patients taking Herceptin. In one clinical trial, 469 patients with metastatic cancer who over-expressed HER2 received either Herceptin with chemotherapy or Herceptin alone. Among the 235 women who received Herceptin with chemotherapy, researchers saw significantly less rapid tumor growth. Many tumors were reduced by 50% or more in size, and the one-year cancer survival rate was higher compared to women who underwent chemotherapy alone (79% versus 68%). Studies conducted after Herceptin received FDA approval continue to show its effectiveness in treating advanced breast cancer patients who carry extra copies of the HER2 gene. In 2005, the National Cancer Institute announced the results of two clinical trials of Herceptin which showed that the drug can offer potentially life-saving treatment to women
