Clinical Trial Looks for Additional Use for Popular Breast Cancer Drug

Saturday, September 13th, 2003

The Breast Cancer International Research Group (BCIRG) is currently conducting a phase III clinical trial in hopes of discovering an additional effective use for the popular breast cancer drug Herceptin.

BCIRG trial # 006 is, for the first time, testing the effectiveness of Herceptin in HER2 positive breast cancer patients in the adjuvant setting.

The study is designed for patients who have had their tumor removed surgically and have no evidence of disease, but are at a high risk for recurrence in the future.

To date, the FDA has only approved Herceptin for the treatment of HER2 positive metastatic breast cancer (in patients whose disease has spread to other parts of the body).

Standard of care for patients with HER2 positive, non-metastatic breast cancer (this trial group) has been the administration of conventional adjuvant chemotherapy.

BCIRG trial #006 is looking specifically at including Herceptin in combination with adjuvant chemotherapy for this patient population.

“This study offers a unique opportunity for women with HER2 positive cancers to receive Herceptin in the adjuvant setting with the aim of reducing the chance of recurrent cancer,” said Dr. Mansoor Saleh, Director of Research at Georgia Cancer Specialists (GCS). “It is a very important study for investigators and patients alike.”

Normal cells have two HER2 gene copies, but, in 25% to 30% of breast cancers, an excess of these genes produces too much protein, which in turn spurs rapid tumor growth.

HER2 positive tumors are generally more likely to recur than tumors that do not overproduce HER2.

Herceptin shrinks and sometimes eliminates tumors by blocking the excess protein created by HER2 genes in cells.

Dr. Saleh said local support has been strong for the study, which is being conducted in 38 countries and looking for more than 3,000 participants.

“GCS has a number of patients enrolled in the study already,” said Dr. Saleh. “These are individuals who have become familiar with the literature, know the potential advantage of Herceptin for HER2 positive tumors, and have decided this trial is right for them.”

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